<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03289728</url>
  </required_header>
  <id_info>
    <org_study_id>38RC17.012</org_study_id>
    <nct_id>NCT03289728</nct_id>
  </id_info>
  <brief_title>Evaluation of a Strategy Guided by Imaging Versus Systematic Coronary Angiography in Elderly Patients With Ischemia</brief_title>
  <acronym>EVAOLD</acronym>
  <official_title>Evaluation of a Strategy Guided by Imaging Versus Systematic Coronary Angiography in Elderly Patients With Ischemia: a Multicentric Randomized Non Inferiority Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Grenoble</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Grenoble</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The WHO predicts that cardiovascular morbi-mortality will increase by 120-137% within 20&#xD;
      years due to the aging population. Myocardial infarction without ST segment elevation&#xD;
      (NSTEMI) is the most common form of infarction. However, its treatment among elderly patients&#xD;
      remains a challenging question.&#xD;
&#xD;
      Indeed, the risk benefit balance of revascularization remains unclear, and complications&#xD;
      related to revascularization are more frequent in the elderly, including MI, heart failure,&#xD;
      stroke, renal failure and bleeding according to National Cardiovascular Network data.The last&#xD;
      randomized controlled trial &quot;After Eighty Study&quot;, showed a reduction of major&#xD;
      cardio-cerebrovascular events (MACCEs) in NSTEMI patients with an invasive strategy&#xD;
      (systematic coronary angiography - CA) compared to a conservative strategy (medical treatment&#xD;
      alone). Nevertheless, this study presented several limitations of which a major one was the&#xD;
      lack of a definition of frailty at inclusion. Moreover, the &quot;After Eighty Study&quot; has shown&#xD;
      that percutaneous revascularization in the invasive arm was only performed for 1 in 2&#xD;
      patients showing an inadequacy in the strategy for selecting candidates for&#xD;
      revascularization.&#xD;
&#xD;
      Consequently, despite European Society of Cardiology (ESC) guidelines, the management of&#xD;
      NSTEMI in elderly patients is not yet evidence based, and current recommendations do not&#xD;
      provide any clear clinical decision rule indicating one strategy over another.&#xD;
&#xD;
      For fragile patients, an alternative strategy consists of selecting candidates for a guided&#xD;
      CA according to the extent of myocardial ischemia, identified by non-invasive imaging.&#xD;
      Single-photon emission computed tomography or dobutamine stress echocardiograms are currently&#xD;
      the reference methods with well-defined interpretation of ischemia. According to our&#xD;
      experience, this strategy avoids CA for one third of patients and improves the rate of&#xD;
      revascularization.&#xD;
&#xD;
      The aim of our study is to compare 1-year morbidity and mortality in NSTEMI patients over 80&#xD;
      years, assigned to guided versus systematic-CA. Our hypothesis is that the guided strategy&#xD;
      will not be inferior on MACE rates at 1 year, and will be cost-effective by reducing&#xD;
      iatrogenic complications.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 4, 2018</start_date>
  <completion_date type="Anticipated">June 2024</completion_date>
  <primary_completion_date type="Anticipated">June 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of MACCE</measure>
    <time_frame>12 months</time_frame>
    <description>Rate of MACCE (defined as all-cause death, non-fatal myocardial infarction, non-fatal stroke)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of MACCEs and each component of the MACCEs criteria during index hospitalization</measure>
    <time_frame>1, 6 and 12 months</time_frame>
    <description>MACCE (defined as all-cause death, non-fatal myocardial infarction, non-fatal stroke)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incremental cost-effectiveness ratio (ICER) expressed as the extra cost for a QALY (quality adjusted life year) gained by the strategy guided by ischemia imaging compared to the systemic coronary angioplasty strategy</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The annual financial impact of implementing the strategy guided by ischemia imaging will be calculated from the French Health Insurance System perspective over three years</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life using standardized scale : EQ5D-5L</measure>
    <time_frame>1, 6 and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frailty assessment</measure>
    <time_frame>1 week</time_frame>
    <description>Multiple assessment are necessary to evaluate patient frailty: ADL, IADL, CAM, MNA, Charlson score, SEGA, MMSE, Time up and go test, mini GDS, history of fall</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dependency (ADL)</measure>
    <time_frame>1, 6, 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Autonomy (IADL)</measure>
    <time_frame>1, 6, 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of bledding events as defined by the Bleeding Research Consortium (BARC) score ≥ 3</measure>
    <time_frame>1. 6, 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of MACCE according to sub-group analysis</measure>
    <time_frame>1. 6, 12 months</time_frame>
    <description>Sub group : age, gender, diabetes, renal failure and frailty</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Create prognostic model with multivariate survival analysis :</measure>
    <time_frame>1. 6, 12 months</time_frame>
    <description>Risk Algorithm, setting up a score to choose an invasive strategy or not based on analysis of different score (for example geriatric score)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of all-cause death, non-fatal myocardial infarction, non-fatal stroke, hospitalization for heart failure, resuscitated cardiac arrest and ischemia-driven coronary revascularization procedure</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1756</enrollment>
  <condition>Myocardial Infarction</condition>
  <arm_group>
    <arm_group_label>Strategy guided by ischemia imaging</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Non-invasive imaging (SPECT or DSE) will be performed. High-risk Patients judged to high risk by imaging (according to ESC guidelines (5)) will undergo coronary angiography aimed at myocardial revascularization and have optimal medical treatment, according to ESC guidelines.&#xD;
- Low or intermediate risk patients will receive optimal medical treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Systematic coronary angioplasty</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will routinely undergo invasive coronary angiography aimed at myocardial revascularization.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Stress single photon emission CT (SPECT) or Stress ultrasound with dobutamine (DSE)</intervention_name>
    <description>Stress single photon emission CT (SPECT) or Stress ultrasound with dobutamine (DSE), performed using standard protocol.&#xD;
Patients with ≥ moderate ischemia observed by SPECT (≥ 10% of the myocardium or transient ischaemic dilatation or reduced post-stress ejection fraction (EF)) or abnormal movements of the myocardial walls observed during a stress echocardiogram (≥ 3/17 segments) will benefit from coronary angiography. Depending on the results of coronary angiography and on the coronary anatomy and other clinical and para-clinical considerations (territory of myocardial ischemia) revascularisation will be performed (REVASC). Patients with &lt; moderate ischemia will receive medical treatment only (MT).</description>
    <arm_group_label>Strategy guided by ischemia imaging</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cornorary angioplasty</intervention_name>
    <description>Participants randomized to the SCA group, will benefit from a coronary angiography within 24 to 72 hours after the diagnosis of NSTEMI; without any preliminary ischemia imaging.</description>
    <arm_group_label>Systematic coronary angioplasty</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged 80 years or older&#xD;
&#xD;
          -  Hospitalized for NSTEMI with or without ST-segment depression on electrocardiogram&#xD;
             (ECG), and with raised blood concentration of troponin T or I. Raised troponin was&#xD;
             defined as a value exceeding the 99th percentile of a normal population at the local&#xD;
             laboratory at each participating site. A local cardiologist assessed patient&#xD;
             eligibility and clinical condition compatible with a doubt for systematic coronary&#xD;
             angiography due to a frailty.&#xD;
&#xD;
          -  Written informed consent by the patient or the next of kin in case of incapacity.&#xD;
&#xD;
        Non-inclusion criteria:&#xD;
&#xD;
          -  Recurrent or ongoing chest pain refractory to medical treatment&#xD;
&#xD;
          -  Haemodynamic instability or cardiogenic shock&#xD;
&#xD;
          -  Life-threatening arrhythmias or cardiac arrest&#xD;
&#xD;
          -  Contra-indication to CA: Renal failure (creatinine clearance &lt;15 mL/min by&#xD;
             Modification of the Diet in Renal Disease (MDRD)), continuing bleeding problems&#xD;
&#xD;
          -  Mechanical complications of MI&#xD;
&#xD;
          -  Severe aortic stenosis&#xD;
&#xD;
          -  Medical history of severe dementia (documented for more than 3 months)&#xD;
&#xD;
          -  Patient under administrative or judicial control&#xD;
&#xD;
          -  Patient who are protected under the act&#xD;
&#xD;
          -  No health care insurance&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>80 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gilles Barone-Rochette, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Grenoble</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Gilles Barone-Rochette, MD, PhD</last_name>
    <phone>+33476765172</phone>
    <email>gbarone@chu-grenoble.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Clémence CHARLON</last_name>
    <email>ccharlon@chu-grenoble.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Clinique Mutualiste</name>
      <address>
        <city>Grenoble</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>BENJAMIN FAURIE, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University Hospital Grenoble</name>
      <address>
        <city>Grenoble</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>GILLES BARONE ROCHETTE, MD PHD</last_name>
    </contact>
    <contact_backup>
      <last_name>CLEMENCE CHARLON</last_name>
      <email>CCHARLON@CHU-GRENOBLE.FR</email>
    </contact_backup>
    <investigator>
      <last_name>GILLES BARONE ROCHETTE, MD PHD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <results_reference>
    <citation>Batchelor WB, Anstrom KJ, Muhlbaier LH, Grosswald R, Weintraub WS, O'Neill WW, Peterson ED. Contemporary outcome trends in the elderly undergoing percutaneous coronary interventions: results in 7,472 octogenarians. National Cardiovascular Network Collaboration. J Am Coll Cardiol. 2000 Sep;36(3):723-30. doi: 10.1016/s0735-1097(00)00777-4.</citation>
    <PMID>10987591</PMID>
  </results_reference>
  <results_reference>
    <citation>Bauer T, Koeth O, Junger C, Heer T, Wienbergen H, Gitt A, Zahn R, Senges J, Zeymer U; Acute Coronary Syndromes Registry (ACOS) Investigators. Effect of an invasive strategy on in-hospital outcome in elderly patients with non-ST-elevation myocardial infarction. Eur Heart J. 2007 Dec;28(23):2873-8. doi: 10.1093/eurheartj/ehm464. Epub 2007 Nov 2.</citation>
    <PMID>17982163</PMID>
  </results_reference>
  <results_reference>
    <citation>Rosengren A, Wallentin L, Simoons M, Gitt AK, Behar S, Battler A, Hasdai D. Age, clinical presentation, and outcome of acute coronary syndromes in the Euroheart acute coronary syndrome survey. Eur Heart J. 2006 Apr;27(7):789-95. doi: 10.1093/eurheartj/ehi774. Epub 2006 Feb 7.</citation>
    <PMID>16464911</PMID>
  </results_reference>
  <results_reference>
    <citation>Wiviott SD, Braunwald E, McCabe CH, Montalescot G, Ruzyllo W, Gottlieb S, Neumann FJ, Ardissino D, De Servi S, Murphy SA, Riesmeyer J, Weerakkody G, Gibson CM, Antman EM; TRITON-TIMI 38 Investigators. Prasugrel versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2007 Nov 15;357(20):2001-15. doi: 10.1056/NEJMoa0706482. Epub 2007 Nov 4.</citation>
    <PMID>17982182</PMID>
  </results_reference>
  <results_reference>
    <citation>Alexander KP, Anstrom KJ, Muhlbaier LH, Grosswald RD, Smith PK, Jones RH, Peterson ED. Outcomes of cardiac surgery in patients &gt; or = 80 years: results from the National Cardiovascular Network. J Am Coll Cardiol. 2000 Mar 1;35(3):731-8. doi: 10.1016/s0735-1097(99)00606-3.</citation>
    <PMID>10716477</PMID>
  </results_reference>
  <results_reference>
    <citation>Wallentin L, Becker RC, Budaj A, Cannon CP, Emanuelsson H, Held C, Horrow J, Husted S, James S, Katus H, Mahaffey KW, Scirica BM, Skene A, Steg PG, Storey RF, Harrington RA; PLATO Investigators; Freij A, Thorsen M. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2009 Sep 10;361(11):1045-57. doi: 10.1056/NEJMoa0904327. Epub 2009 Aug 30.</citation>
    <PMID>19717846</PMID>
  </results_reference>
  <results_reference>
    <citation>Wallentin L, Lagerqvist B, Husted S, Kontny F, Stahle E, Swahn E. Outcome at 1 year after an invasive compared with a non-invasive strategy in unstable coronary-artery disease: the FRISC II invasive randomised trial. FRISC II Investigators. Fast Revascularisation during Instability in Coronary artery disease. Lancet. 2000 Jul 1;356(9223):9-16. doi: 10.1016/s0140-6736(00)02427-2.</citation>
    <PMID>10892758</PMID>
  </results_reference>
  <results_reference>
    <citation>Lagerqvist B, Husted S, Kontny F, Stahle E, Swahn E, Wallentin L; Fast Revascularisation during InStability in Coronary artery disease (FRISC-II) Investigators. 5-year outcomes in the FRISC-II randomised trial of an invasive versus a non-invasive strategy in non-ST-elevation acute coronary syndrome: a follow-up study. Lancet. 2006 Sep 16;368(9540):998-1004. doi: 10.1016/S0140-6736(06)69416-6.</citation>
    <PMID>16980115</PMID>
  </results_reference>
  <results_reference>
    <citation>Fox KA, Clayton TC, Damman P, Pocock SJ, de Winter RJ, Tijssen JG, Lagerqvist B, Wallentin L; FIR Collaboration. Long-term outcome of a routine versus selective invasive strategy in patients with non-ST-segment elevation acute coronary syndrome a meta-analysis of individual patient data. J Am Coll Cardiol. 2010 Jun 1;55(22):2435-45. doi: 10.1016/j.jacc.2010.03.007. Epub 2010 Mar 30.</citation>
    <PMID>20359842</PMID>
  </results_reference>
  <results_reference>
    <citation>Savonitto S, Cavallini C, Petronio AS, Murena E, Antonicelli R, Sacco A, Steffenino G, Bonechi F, Mossuti E, Manari A, Tolaro S, Toso A, Daniotti A, Piscione F, Morici N, Cesana BM, Jori MC, De Servi S; Italian Elderly ACS Trial Investigators. Early aggressive versus initially conservative treatment in elderly patients with non-ST-segment elevation acute coronary syndrome: a randomized controlled trial. JACC Cardiovasc Interv. 2012 Sep;5(9):906-16. doi: 10.1016/j.jcin.2012.06.008.</citation>
    <PMID>22995877</PMID>
  </results_reference>
  <results_reference>
    <citation>Tegn N, Abdelnoor M, Aaberge L, Endresen K, Smith P, Aakhus S, Gjertsen E, Dahl-Hofseth O, Ranhoff AH, Gullestad L, Bendz B; After Eighty study investigators. Invasive versus conservative strategy in patients aged 80 years or older with non-ST-elevation myocardial infarction or unstable angina pectoris (After Eighty study): an open-label randomised controlled trial. Lancet. 2016 Mar 12;387(10023):1057-1065. doi: 10.1016/S0140-6736(15)01166-6. Epub 2016 Jan 13.</citation>
    <PMID>26794722</PMID>
  </results_reference>
  <results_reference>
    <citation>Afilalo J, Alexander KP, Mack MJ, Maurer MS, Green P, Allen LA, Popma JJ, Ferrucci L, Forman DE. Frailty assessment in the cardiovascular care of older adults. J Am Coll Cardiol. 2014 Mar 4;63(8):747-62. doi: 10.1016/j.jacc.2013.09.070. Epub 2013 Nov 27.</citation>
    <PMID>24291279</PMID>
  </results_reference>
  <results_reference>
    <citation>Ekerstad N, Swahn E, Janzon M, Alfredsson J, Lofmark R, Lindenberger M, Carlsson P. Frailty is independently associated with short-term outcomes for elderly patients with non-ST-segment elevation myocardial infarction. Circulation. 2011 Nov 29;124(22):2397-404. doi: 10.1161/CIRCULATIONAHA.111.025452. Epub 2011 Nov 7.</citation>
    <PMID>22064593</PMID>
  </results_reference>
  <results_reference>
    <citation>Roffi M, Patrono C, Collet JP, Mueller C, Valgimigli M, Andreotti F, Bax JJ, Borger MA, Brotons C, Chew DP, Gencer B, Hasenfuss G, Kjeldsen K, Lancellotti P, Landmesser U, Mehilli J, Mukherjee D, Storey RF, Windecker S. [2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation. Task Force for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-Segment Elevation of the European Society of Cardiology (ESC)]. G Ital Cardiol (Rome). 2016 Oct;17(10):831-872. doi: 10.1714/2464.25804. No abstract available. Italian.</citation>
    <PMID>27869901</PMID>
  </results_reference>
  <results_reference>
    <citation>Task Force Members; Montalescot G, Sechtem U, Achenbach S, Andreotti F, Arden C, Budaj A, Bugiardini R, Crea F, Cuisset T, Di Mario C, Ferreira JR, Gersh BJ, Gitt AK, Hulot JS, Marx N, Opie LH, Pfisterer M, Prescott E, Ruschitzka F, Sabate M, Senior R, Taggart DP, van der Wall EE, Vrints CJ; ESC Committee for Practice Guidelines; Zamorano JL, Achenbach S, Baumgartner H, Bax JJ, Bueno H, Dean V, Deaton C, Erol C, Fagard R, Ferrari R, Hasdai D, Hoes AW, Kirchhof P, Knuuti J, Kolh P, Lancellotti P, Linhart A, Nihoyannopoulos P, Piepoli MF, Ponikowski P, Sirnes PA, Tamargo JL, Tendera M, Torbicki A, Wijns W, Windecker S; Document Reviewers; Knuuti J, Valgimigli M, Bueno H, Claeys MJ, Donner-Banzhoff N, Erol C, Frank H, Funck-Brentano C, Gaemperli O, Gonzalez-Juanatey JR, Hamilos M, Hasdai D, Husted S, James SK, Kervinen K, Kolh P, Kristensen SD, Lancellotti P, Maggioni AP, Piepoli MF, Pries AR, Romeo F, Ryden L, Simoons ML, Sirnes PA, Steg PG, Timmis A, Wijns W, Windecker S, Yildirir A, Zamorano JL. 2013 ESC guidelines on the management of stable coronary artery disease: the Task Force on the management of stable coronary artery disease of the European Society of Cardiology. Eur Heart J. 2013 Oct;34(38):2949-3003. doi: 10.1093/eurheartj/eht296. Epub 2013 Aug 30. No abstract available. Erratum In: Eur Heart J. 2014 Sep 1;35(33):2260-1.</citation>
    <PMID>23996286</PMID>
  </results_reference>
  <results_reference>
    <citation>Thygesen K, Alpert JS, White HD; Joint ESC/ACCF/AHA/WHF Task Force for the Redefinition of Myocardial Infarction. Universal definition of myocardial infarction. J Am Coll Cardiol. 2007 Nov 27;50(22):2173-95. doi: 10.1016/j.jacc.2007.09.011. No abstract available.</citation>
    <PMID>18036459</PMID>
  </results_reference>
  <results_reference>
    <citation>Manrique A, Marie PY, Agostini D, Maunoury C, Acar P; Groupe de travail Cardiologie nucleaire et IRM. [Update of recommendations for nuclear cardiology stress tests in adults and children]. Arch Mal Coeur Vaiss. 2002 Sep;95(9):851-72. No abstract available. French.</citation>
    <PMID>12407803</PMID>
  </results_reference>
  <results_reference>
    <citation>Furber A, Berdague P, Cadiou C, David N, Faraggi M, Fourquet N, Helias J, Le Guludec D, Marie PY, Ouhayoun E, Pezard P, Vanzetto G, Weinmann P; Groupe de travail Cardiologie nucleaire et IRM. [Recommendations of the French Society of Cardiology concerning the practice of ischemia provocation tests in adult nuclear cardiology]. Arch Mal Coeur Vaiss. 2000 Nov;93(11):1309-32. No abstract available. French.</citation>
    <PMID>11190460</PMID>
  </results_reference>
  <results_reference>
    <citation>Manrique A, Marie PY; Nuclear Cardiology MRI Group. [Recommendations for the performance and interpretation of myocardial perfusion tomoscintigraphy]. Arch Mal Coeur Vaiss. 2003 Jun;96(6):695-711. No abstract available. French.</citation>
    <PMID>12868353</PMID>
  </results_reference>
  <results_reference>
    <citation>Verberne HJ, Acampa W, Anagnostopoulos C, Ballinger J, Bengel F, De Bondt P, Buechel RR, Cuocolo A, van Eck-Smit BL, Flotats A, Hacker M, Hindorf C, Kaufmann PA, Lindner O, Ljungberg M, Lonsdale M, Manrique A, Minarik D, Scholte AJ, Slart RH, Tragardh E, de Wit TC, Hesse B; European Association of Nuclear Medicine (EANM). EANM procedural guidelines for radionuclide myocardial perfusion imaging with SPECT and SPECT/CT: 2015 revision. Eur J Nucl Med Mol Imaging. 2015 Nov;42(12):1929-40. doi: 10.1007/s00259-015-3139-x. Epub 2015 Aug 21.</citation>
    <PMID>26290421</PMID>
  </results_reference>
  <results_reference>
    <citation>Cerqueira MD, Weissman NJ, Dilsizian V, Jacobs AK, Kaul S, Laskey WK, Pennell DJ, Rumberger JA, Ryan T, Verani MS; American Heart Association Writing Group on Myocardial Segmentation and Registration for Cardiac Imaging. Standardized myocardial segmentation and nomenclature for tomographic imaging of the heart. A statement for healthcare professionals from the Cardiac Imaging Committee of the Council on Clinical Cardiology of the American Heart Association. Int J Cardiovasc Imaging. 2002 Feb;18(1):539-42. No abstract available.</citation>
    <PMID>12135124</PMID>
  </results_reference>
  <results_reference>
    <citation>Sicari R, Nihoyannopoulos P, Evangelista A, Kasprzak J, Lancellotti P, Poldermans D, Voigt JU, Zamorano JL; European Association of Echocardiography. Stress Echocardiography Expert Consensus Statement--Executive Summary: European Association of Echocardiography (EAE) (a registered branch of the ESC). Eur Heart J. 2009 Feb;30(3):278-89. doi: 10.1093/eurheartj/ehn492. Epub 2008 Nov 11. No abstract available.</citation>
    <PMID>19001473</PMID>
  </results_reference>
  <results_reference>
    <citation>Lang RM, Bierig M, Devereux RB, Flachskampf FA, Foster E, Pellikka PA, Picard MH, Roman MJ, Seward J, Shanewise JS, Solomon SD, Spencer KT, Sutton MS, Stewart WJ; Chamber Quantification Writing Group; American Society of Echocardiography's Guidelines and Standards Committee; European Association of Echocardiography. Recommendations for chamber quantification: a report from the American Society of Echocardiography's Guidelines and Standards Committee and the Chamber Quantification Writing Group, developed in conjunction with the European Association of Echocardiography, a branch of the European Society of Cardiology. J Am Soc Echocardiogr. 2005 Dec;18(12):1440-63. doi: 10.1016/j.echo.2005.10.005. No abstract available.</citation>
    <PMID>16376782</PMID>
  </results_reference>
  <results_reference>
    <citation>Authors/Task Force members; Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Juni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Sousa Uva M, Stefanini GG, Taggart DP, Torracca L, Valgimigli M, Wijns W, Witkowski A. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2014 Oct 1;35(37):2541-619. doi: 10.1093/eurheartj/ehu278. Epub 2014 Aug 29. No abstract available.</citation>
    <PMID>25173339</PMID>
  </results_reference>
  <results_reference>
    <citation>Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. No abstract available.</citation>
    <PMID>21670242</PMID>
  </results_reference>
  <results_reference>
    <citation>Lakatos E, Lan KK. A comparison of sample size methods for the logrank statistic. Stat Med. 1992 Jan 30;11(2):179-91. doi: 10.1002/sim.4780110205.</citation>
    <PMID>1579757</PMID>
  </results_reference>
  <results_reference>
    <citation>Com-Nougue C, Rodary C, Patte C. How to establish equivalence when data are censored: a randomized trial of treatments for B non-Hodgkin lymphoma. Stat Med. 1993 Jul 30;12(14):1353-64. doi: 10.1002/sim.4780121407.</citation>
    <PMID>8210831</PMID>
  </results_reference>
  <results_reference>
    <citation>Rothmann M, Li N, Chen G, Chi GY, Temple R, Tsou HH. Design and analysis of non-inferiority mortality trials in oncology. Stat Med. 2003 Jan 30;22(2):239-64. doi: 10.1002/sim.1400.</citation>
    <PMID>12520560</PMID>
  </results_reference>
  <results_reference>
    <citation>Fleming TR, Harrington DP, O'Brien PC. Designs for group sequential tests. Control Clin Trials. 1984 Dec;5(4):348-61. doi: 10.1016/s0197-2456(84)80014-8.</citation>
    <PMID>6518769</PMID>
  </results_reference>
  <results_reference>
    <citation>Chevalier J, de Pouvourville G. Valuing EQ-5D using time trade-off in France. Eur J Health Econ. 2013 Feb;14(1):57-66. doi: 10.1007/s10198-011-0351-x. Epub 2011 Sep 21.</citation>
    <PMID>21935715</PMID>
  </results_reference>
  <results_reference>
    <citation>Manca A, Hawkins N, Sculpher MJ. Estimating mean QALYs in trial-based cost-effectiveness analysis: the importance of controlling for baseline utility. Health Econ. 2005 May;14(5):487-96. doi: 10.1002/hec.944.</citation>
    <PMID>15497198</PMID>
  </results_reference>
  <results_reference>
    <citation>Sullivan SD, Mauskopf JA, Augustovski F, Jaime Caro J, Lee KM, Minchin M, Orlewska E, Penna P, Rodriguez Barrios JM, Shau WY. Budget impact analysis-principles of good practice: report of the ISPOR 2012 Budget Impact Analysis Good Practice II Task Force. Value Health. 2014 Jan-Feb;17(1):5-14. doi: 10.1016/j.jval.2013.08.2291. Epub 2013 Dec 13.</citation>
    <PMID>24438712</PMID>
  </results_reference>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>June 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 21, 2017</study_first_posted>
  <last_update_submitted>May 25, 2023</last_update_submitted>
  <last_update_submitted_qc>May 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 30, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>elderly patients</keyword>
  <keyword>myocardial infarction</keyword>
  <keyword>myocardial revascularization strategy</keyword>
  <keyword>ischemia imaging</keyword>
  <keyword>coronary artery disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Infarction</mesh_term>
    <mesh_term>Ischemia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dobutamine</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03289728
org study id: 38RC17.012
nct id: NCT03289728
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The WHO predicts that cardiovascular morbi-mortality will increase by 120-137% within 20
      years due to the aging population. Myocardial infarction without ST segment elevation
      (NSTEMI) is the most common form of infarction. However, its treatment among elderly patients
      remains a challenging question.

      Indeed, the risk benefit balance of revascularization remains unclear, and complications
      related to revascularization are more frequent in the elderly, including MI, heart failure,
      stroke, renal failure and bleeding according to National Cardiovascular Network data.The last
      randomized controlled trial "After Eighty Study", showed a reduction of major
      cardio-cerebrovascular events (MACCEs) in NSTEMI patients with an invasive strategy
      (systematic coronary angiography - CA) compared to a conservative strategy (medical treatment
      alone). Nevertheless, this study presented several limitations of which a major one was the
      lack of a definition of frailty at inclusion. Moreover, the "After Eighty Study" has shown
      that percutaneous revascularization in the invasive arm was only performed for 1 in 2
      patients showing an inadequacy in the strategy for selecting candidates for
      revascularization.

      Consequently, despite European Society of Cardiology (ESC) guidelines, the management of
      NSTEMI in elderly patients is not yet evidence based, and current recommendations do not
      provide any clear clinical decision rule indicating one strategy over another.

      For fragile patients, an alternative strategy consists of selecting candidates for a guided
      CA according to the extent of myocardial ischemia, identified by non-invasive imaging.
      Single-photon emission computed tomography or dobutamine stress echocardiograms are currently
      the reference methods with well-defined interpretation of ischemia. According to our
      experience, this strategy avoids CA for one third of patients and improves the rate of
      revascularization.

      The aim of our study is to compare 1-year morbidity and mortality in NSTEMI patients over 80
      years, assigned to guided versus systematic-CA. Our hypothesis is that the guided strategy
      will not be inferior on MACE rates at 1 year, and will be cost-effective by reducing
      iatrogenic complications.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Rate of MACCE
time frame: 12 months
description: Rate of MACCE (defined as all-cause death, non-fatal myocardial infarction, non-fatal stroke)
measure: Rate of MACCEs and each component of the MACCEs criteria during index hospitalization
time frame: 1, 6 and 12 months
description: MACCE (defined as all-cause death, non-fatal myocardial infarction, non-fatal stroke)
measure: Incremental cost-effectiveness ratio (ICER) expressed as the extra cost for a QALY (quality adjusted life year) gained by the strategy guided by ischemia imaging compared to the systemic coronary angioplasty strategy
time frame: 12 months
measure: The annual financial impact of implementing the strategy guided by ischemia imaging will be calculated from the French Health Insurance System perspective over three years
time frame: 12 months
measure: Quality of life using standardized scale : EQ5D-5L
time frame: 1, 6 and 12 months
measure: Frailty assessment
time frame: 1 week
description: Multiple assessment are necessary to evaluate patient frailty: ADL, IADL, CAM, MNA, Charlson score, SEGA, MMSE, Time up and go test, mini GDS, history of fall
measure: Dependency (ADL)
time frame: 1, 6, 12 months
measure: Autonomy (IADL)
time frame: 1, 6, 12 months
measure: Incidence of bledding events as defined by the Bleeding Research Consortium (BARC) score ≥ 3
time frame: 1. 6, 12 months
measure: Rate of MACCE according to sub-group analysis
time frame: 1. 6, 12 months
description: Sub group : age, gender, diabetes, renal failure and frailty
measure: Create prognostic model with multivariate survival analysis :
time frame: 1. 6, 12 months
description: Risk Algorithm, setting up a score to choose an invasive strategy or not based on analysis of different score (for example geriatric score)
measure: Rate of all-cause death, non-fatal myocardial infarction, non-fatal stroke, hospitalization for heart failure, resuscitated cardiac arrest and ischemia-driven coronary revascularization procedure
time frame: 12 months
arm group label: Strategy guided by ischemia imaging
arm group type: Experimental
description: Non-invasive imaging (SPECT or DSE) will be performed. High-risk Patients judged to high risk by imaging (according to ESC guidelines (5)) will undergo coronary angiography aimed at myocardial revascularization and have optimal medical treatment, according to ESC guidelines.
- Low or intermediate risk patients will receive optimal medical treatment.
arm group label: Systematic coronary angioplasty
arm group type: Active Comparator
description: Patients will routinely undergo invasive coronary angiography aimed at myocardial revascularization.
intervention type: Other
intervention name: Stress single photon emission CT (SPECT) or Stress ultrasound with dobutamine (DSE)
description: Stress single photon emission CT (SPECT) or Stress ultrasound with dobutamine (DSE), performed using standard protocol.
Patients with ≥ moderate ischemia observed by SPECT (≥ 10% of the myocardium or transient ischaemic dilatation or reduced post-stress ejection fraction (EF)) or abnormal movements of the myocardial walls observed during a stress echocardiogram (≥ 3/17 segments) will benefit from coronary angiography. Depending on the results of coronary angiography and on the coronary anatomy and other clinical and para-clinical considerations (territory of myocardial ischemia) revascularisation will be performed (REVASC). Patients with < moderate ischemia will receive medical treatment only (MT).
arm group label: Strategy guided by ischemia imaging
intervention type: Procedure
intervention name: Cornorary angioplasty
description: Participants randomized to the SCA group, will benefit from a coronary angiography within 24 to 72 hours after the diagnosis of NSTEMI; without any preliminary ischemia imaging.
arm group label: Systematic coronary angioplasty
criteria: 
gender: All
minimum age: 80 Years
maximum age: N/A
healthy volunteers: No
last name: Gilles Barone-Rochette, MD, PhD
role: Principal Investigator
affiliation: University Hospital, Grenoble
last name: Gilles Barone-Rochette, MD, PhD
phone: +33476765172
email: gbarone@chu-grenoble.fr
last name: Clémence CHARLON
email: ccharlon@chu-grenoble.fr
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: France
citation: Batchelor WB, Anstrom KJ, Muhlbaier LH, Grosswald R, Weintraub WS, O'Neill WW, Peterson ED. Contemporary outcome trends in the elderly undergoing percutaneous coronary interventions: results in 7,472 octogenarians. National Cardiovascular Network Collaboration. J Am Coll Cardiol. 2000 Sep;36(3):723-30. doi: 10.1016/s0735-1097(00)00777-4.
PMID: 10987591
citation: Bauer T, Koeth O, Junger C, Heer T, Wienbergen H, Gitt A, Zahn R, Senges J, Zeymer U; Acute Coronary Syndromes Registry (ACOS) Investigators. Effect of an invasive strategy on in-hospital outcome in elderly patients with non-ST-elevation myocardial infarction. Eur Heart J. 2007 Dec;28(23):2873-8. doi: 10.1093/eurheartj/ehm464. Epub 2007 Nov 2.
PMID: 17982163
citation: Rosengren A, Wallentin L, Simoons M, Gitt AK, Behar S, Battler A, Hasdai D. Age, clinical presentation, and outcome of acute coronary syndromes in the Euroheart acute coronary syndrome survey. Eur Heart J. 2006 Apr;27(7):789-95. doi: 10.1093/eurheartj/ehi774. Epub 2006 Feb 7.
PMID: 16464911
citation: Wiviott SD, Braunwald E, McCabe CH, Montalescot G, Ruzyllo W, Gottlieb S, Neumann FJ, Ardissino D, De Servi S, Murphy SA, Riesmeyer J, Weerakkody G, Gibson CM, Antman EM; TRITON-TIMI 38 Investigators. Prasugrel versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2007 Nov 15;357(20):2001-15. doi: 10.1056/NEJMoa0706482. Epub 2007 Nov 4.
PMID: 17982182
citation: Alexander KP, Anstrom KJ, Muhlbaier LH, Grosswald RD, Smith PK, Jones RH, Peterson ED. Outcomes of cardiac surgery in patients > or = 80 years: results from the National Cardiovascular Network. J Am Coll Cardiol. 2000 Mar 1;35(3):731-8. doi: 10.1016/s0735-1097(99)00606-3.
PMID: 10716477
citation: Wallentin L, Becker RC, Budaj A, Cannon CP, Emanuelsson H, Held C, Horrow J, Husted S, James S, Katus H, Mahaffey KW, Scirica BM, Skene A, Steg PG, Storey RF, Harrington RA; PLATO Investigators; Freij A, Thorsen M. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2009 Sep 10;361(11):1045-57. doi: 10.1056/NEJMoa0904327. Epub 2009 Aug 30.
PMID: 19717846
citation: Wallentin L, Lagerqvist B, Husted S, Kontny F, Stahle E, Swahn E. Outcome at 1 year after an invasive compared with a non-invasive strategy in unstable coronary-artery disease: the FRISC II invasive randomised trial. FRISC II Investigators. Fast Revascularisation during Instability in Coronary artery disease. Lancet. 2000 Jul 1;356(9223):9-16. doi: 10.1016/s0140-6736(00)02427-2.
PMID: 10892758
citation: Lagerqvist B, Husted S, Kontny F, Stahle E, Swahn E, Wallentin L; Fast Revascularisation during InStability in Coronary artery disease (FRISC-II) Investigators. 5-year outcomes in the FRISC-II randomised trial of an invasive versus a non-invasive strategy in non-ST-elevation acute coronary syndrome: a follow-up study. Lancet. 2006 Sep 16;368(9540):998-1004. doi: 10.1016/S0140-6736(06)69416-6.
PMID: 16980115
citation: Fox KA, Clayton TC, Damman P, Pocock SJ, de Winter RJ, Tijssen JG, Lagerqvist B, Wallentin L; FIR Collaboration. Long-term outcome of a routine versus selective invasive strategy in patients with non-ST-segment elevation acute coronary syndrome a meta-analysis of individual patient data. J Am Coll Cardiol. 2010 Jun 1;55(22):2435-45. doi: 10.1016/j.jacc.2010.03.007. Epub 2010 Mar 30.
PMID: 20359842
citation: Savonitto S, Cavallini C, Petronio AS, Murena E, Antonicelli R, Sacco A, Steffenino G, Bonechi F, Mossuti E, Manari A, Tolaro S, Toso A, Daniotti A, Piscione F, Morici N, Cesana BM, Jori MC, De Servi S; Italian Elderly ACS Trial Investigators. Early aggressive versus initially conservative treatment in elderly patients with non-ST-segment elevation acute coronary syndrome: a randomized controlled trial. JACC Cardiovasc Interv. 2012 Sep;5(9):906-16. doi: 10.1016/j.jcin.2012.06.008.
PMID: 22995877
citation: Tegn N, Abdelnoor M, Aaberge L, Endresen K, Smith P, Aakhus S, Gjertsen E, Dahl-Hofseth O, Ranhoff AH, Gullestad L, Bendz B; After Eighty study investigators. Invasive versus conservative strategy in patients aged 80 years or older with non-ST-elevation myocardial infarction or unstable angina pectoris (After Eighty study): an open-label randomised controlled trial. Lancet. 2016 Mar 12;387(10023):1057-1065. doi: 10.1016/S0140-6736(15)01166-6. Epub 2016 Jan 13.
PMID: 26794722
citation: Afilalo J, Alexander KP, Mack MJ, Maurer MS, Green P, Allen LA, Popma JJ, Ferrucci L, Forman DE. Frailty assessment in the cardiovascular care of older adults. J Am Coll Cardiol. 2014 Mar 4;63(8):747-62. doi: 10.1016/j.jacc.2013.09.070. Epub 2013 Nov 27.
PMID: 24291279
citation: Ekerstad N, Swahn E, Janzon M, Alfredsson J, Lofmark R, Lindenberger M, Carlsson P. Frailty is independently associated with short-term outcomes for elderly patients with non-ST-segment elevation myocardial infarction. Circulation. 2011 Nov 29;124(22):2397-404. doi: 10.1161/CIRCULATIONAHA.111.025452. Epub 2011 Nov 7.
PMID: 22064593
citation: Roffi M, Patrono C, Collet JP, Mueller C, Valgimigli M, Andreotti F, Bax JJ, Borger MA, Brotons C, Chew DP, Gencer B, Hasenfuss G, Kjeldsen K, Lancellotti P, Landmesser U, Mehilli J, Mukherjee D, Storey RF, Windecker S. [2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation. Task Force for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-Segment Elevation of the European Society of Cardiology (ESC)]. G Ital Cardiol (Rome). 2016 Oct;17(10):831-872. doi: 10.1714/2464.25804. No abstract available. Italian.
PMID: 27869901
citation: Task Force Members; Montalescot G, Sechtem U, Achenbach S, Andreotti F, Arden C, Budaj A, Bugiardini R, Crea F, Cuisset T, Di Mario C, Ferreira JR, Gersh BJ, Gitt AK, Hulot JS, Marx N, Opie LH, Pfisterer M, Prescott E, Ruschitzka F, Sabate M, Senior R, Taggart DP, van der Wall EE, Vrints CJ; ESC Committee for Practice Guidelines; Zamorano JL, Achenbach S, Baumgartner H, Bax JJ, Bueno H, Dean V, Deaton C, Erol C, Fagard R, Ferrari R, Hasdai D, Hoes AW, Kirchhof P, Knuuti J, Kolh P, Lancellotti P, Linhart A, Nihoyannopoulos P, Piepoli MF, Ponikowski P, Sirnes PA, Tamargo JL, Tendera M, Torbicki A, Wijns W, Windecker S; Document Reviewers; Knuuti J, Valgimigli M, Bueno H, Claeys MJ, Donner-Banzhoff N, Erol C, Frank H, Funck-Brentano C, Gaemperli O, Gonzalez-Juanatey JR, Hamilos M, Hasdai D, Husted S, James SK, Kervinen K, Kolh P, Kristensen SD, Lancellotti P, Maggioni AP, Piepoli MF, Pries AR, Romeo F, Ryden L, Simoons ML, Sirnes PA, Steg PG, Timmis A, Wijns W, Windecker S, Yildirir A, Zamorano JL. 2013 ESC guidelines on the management of stable coronary artery disease: the Task Force on the management of stable coronary artery disease of the European Society of Cardiology. Eur Heart J. 2013 Oct;34(38):2949-3003. doi: 10.1093/eurheartj/eht296. Epub 2013 Aug 30. No abstract available. Erratum In: Eur Heart J. 2014 Sep 1;35(33):2260-1.
PMID: 23996286
citation: Thygesen K, Alpert JS, White HD; Joint ESC/ACCF/AHA/WHF Task Force for the Redefinition of Myocardial Infarction. Universal definition of myocardial infarction. J Am Coll Cardiol. 2007 Nov 27;50(22):2173-95. doi: 10.1016/j.jacc.2007.09.011. No abstract available.
PMID: 18036459
citation: Manrique A, Marie PY, Agostini D, Maunoury C, Acar P; Groupe de travail Cardiologie nucleaire et IRM. [Update of recommendations for nuclear cardiology stress tests in adults and children]. Arch Mal Coeur Vaiss. 2002 Sep;95(9):851-72. No abstract available. French.
PMID: 12407803
citation: Furber A, Berdague P, Cadiou C, David N, Faraggi M, Fourquet N, Helias J, Le Guludec D, Marie PY, Ouhayoun E, Pezard P, Vanzetto G, Weinmann P; Groupe de travail Cardiologie nucleaire et IRM. [Recommendations of the French Society of Cardiology concerning the practice of ischemia provocation tests in adult nuclear cardiology]. Arch Mal Coeur Vaiss. 2000 Nov;93(11):1309-32. No abstract available. French.
PMID: 11190460
citation: Manrique A, Marie PY; Nuclear Cardiology MRI Group. [Recommendations for the performance and interpretation of myocardial perfusion tomoscintigraphy]. Arch Mal Coeur Vaiss. 2003 Jun;96(6):695-711. No abstract available. French.
PMID: 12868353
citation: Verberne HJ, Acampa W, Anagnostopoulos C, Ballinger J, Bengel F, De Bondt P, Buechel RR, Cuocolo A, van Eck-Smit BL, Flotats A, Hacker M, Hindorf C, Kaufmann PA, Lindner O, Ljungberg M, Lonsdale M, Manrique A, Minarik D, Scholte AJ, Slart RH, Tragardh E, de Wit TC, Hesse B; European Association of Nuclear Medicine (EANM). EANM procedural guidelines for radionuclide myocardial perfusion imaging with SPECT and SPECT/CT: 2015 revision. Eur J Nucl Med Mol Imaging. 2015 Nov;42(12):1929-40. doi: 10.1007/s00259-015-3139-x. Epub 2015 Aug 21.
PMID: 26290421
citation: Cerqueira MD, Weissman NJ, Dilsizian V, Jacobs AK, Kaul S, Laskey WK, Pennell DJ, Rumberger JA, Ryan T, Verani MS; American Heart Association Writing Group on Myocardial Segmentation and Registration for Cardiac Imaging. Standardized myocardial segmentation and nomenclature for tomographic imaging of the heart. A statement for healthcare professionals from the Cardiac Imaging Committee of the Council on Clinical Cardiology of the American Heart Association. Int J Cardiovasc Imaging. 2002 Feb;18(1):539-42. No abstract available.
PMID: 12135124
citation: Sicari R, Nihoyannopoulos P, Evangelista A, Kasprzak J, Lancellotti P, Poldermans D, Voigt JU, Zamorano JL; European Association of Echocardiography. Stress Echocardiography Expert Consensus Statement--Executive Summary: European Association of Echocardiography (EAE) (a registered branch of the ESC). Eur Heart J. 2009 Feb;30(3):278-89. doi: 10.1093/eurheartj/ehn492. Epub 2008 Nov 11. No abstract available.
PMID: 19001473
citation: Lang RM, Bierig M, Devereux RB, Flachskampf FA, Foster E, Pellikka PA, Picard MH, Roman MJ, Seward J, Shanewise JS, Solomon SD, Spencer KT, Sutton MS, Stewart WJ; Chamber Quantification Writing Group; American Society of Echocardiography's Guidelines and Standards Committee; European Association of Echocardiography. Recommendations for chamber quantification: a report from the American Society of Echocardiography's Guidelines and Standards Committee and the Chamber Quantification Writing Group, developed in conjunction with the European Association of Echocardiography, a branch of the European Society of Cardiology. J Am Soc Echocardiogr. 2005 Dec;18(12):1440-63. doi: 10.1016/j.echo.2005.10.005. No abstract available.
PMID: 16376782
citation: Authors/Task Force members; Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Juni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Sousa Uva M, Stefanini GG, Taggart DP, Torracca L, Valgimigli M, Wijns W, Witkowski A. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2014 Oct 1;35(37):2541-619. doi: 10.1093/eurheartj/ehu278. Epub 2014 Aug 29. No abstract available.
PMID: 25173339
citation: Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. No abstract available.
PMID: 21670242
citation: Lakatos E, Lan KK. A comparison of sample size methods for the logrank statistic. Stat Med. 1992 Jan 30;11(2):179-91. doi: 10.1002/sim.4780110205.
PMID: 1579757
citation: Com-Nougue C, Rodary C, Patte C. How to establish equivalence when data are censored: a randomized trial of treatments for B non-Hodgkin lymphoma. Stat Med. 1993 Jul 30;12(14):1353-64. doi: 10.1002/sim.4780121407.
PMID: 8210831
citation: Rothmann M, Li N, Chen G, Chi GY, Temple R, Tsou HH. Design and analysis of non-inferiority mortality trials in oncology. Stat Med. 2003 Jan 30;22(2):239-64. doi: 10.1002/sim.1400.
PMID: 12520560
citation: Fleming TR, Harrington DP, O'Brien PC. Designs for group sequential tests. Control Clin Trials. 1984 Dec;5(4):348-61. doi: 10.1016/s0197-2456(84)80014-8.
PMID: 6518769
citation: Chevalier J, de Pouvourville G. Valuing EQ-5D using time trade-off in France. Eur J Health Econ. 2013 Feb;14(1):57-66. doi: 10.1007/s10198-011-0351-x. Epub 2011 Sep 21.
PMID: 21935715
citation: Manca A, Hawkins N, Sculpher MJ. Estimating mean QALYs in trial-based cost-effectiveness analysis: the importance of controlling for baseline utility. Health Econ. 2005 May;14(5):487-96. doi: 10.1002/hec.944.
PMID: 15497198
citation: Sullivan SD, Mauskopf JA, Augustovski F, Jaime Caro J, Lee KM, Minchin M, Orlewska E, Penna P, Rodriguez Barrios JM, Shau WY. Budget impact analysis-principles of good practice: report of the ISPOR 2012 Budget Impact Analysis Good Practice II Task Force. Value Health. 2014 Jan-Feb;17(1):5-14. doi: 10.1016/j.jval.2013.08.2291. Epub 2013 Dec 13.
PMID: 24438712
responsible party type: Sponsor
mesh term: Myocardial Infarction
mesh term: Infarction
mesh term: Ischemia
mesh term: Dobutamine