<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/NCT02240745</url>
  </required_header>
  <id_info>
    <org_study_id>039/14</org_study_id>
    <secondary_id>SNCTP 0761</secondary_id>
    <nct_id>NCT02240745</nct_id>
  </id_info>
  <brief_title>New Three-dimensional Methods of Analysis for the Detection of Coronary Artery Disease by Dobutamine Stress Echocardiography</brief_title>
  <acronym>3-DSE</acronym>
  <official_title>New Three-dimensional Methods of Analysis for the Detection of Coronary Artery Disease by Dobutamine Stress Echocardiography</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Insel Gruppe AG, University Hospital Bern</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Insel Gruppe AG, University Hospital Bern</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators are going to recruit patients who have a scheduled elective coronary&#xD;
      angiography and going to do a dobutamin stress echography (DSE) before the coronary&#xD;
      examination. Next to a regular 2D-DSE, the investigators will perform an 3-dimensional DSE,&#xD;
      incl ventriculography. In the interventional part (coronary angiography), they will measure&#xD;
      each stenosis with fractional flow-reserve (FFR)and herewith graduate its stenosis severity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background&#xD;
&#xD;
      Coronary heart disease is the leading cause of death worldwide. Non-invasive, radiation-free&#xD;
      diagnostic needs further improvement. In this study, the investigators test the hypothesis&#xD;
      that their method, which measures the myocardial deformation using 3D echocardiography is&#xD;
      superior to previous ultrasound technologies with regard to diagnosis of stable coronary&#xD;
      artery disease. The aim is establish an improved, non-invasive method to diagnose stable&#xD;
      coronary artery disease.&#xD;
&#xD;
      Objective&#xD;
&#xD;
      The investigators want to investigate if a 3D-speckle-tracking is superior and more accurate&#xD;
      in predicting hemodynamically significant coronary artery stenosis than predicted by 2D&#xD;
      echocardiography? The reference variable for the hemodynamic significance of coronary artery&#xD;
      stenosis is invasively measured by coronary flow reserve (CFR) in consideration of collateral&#xD;
      flow (CFI).&#xD;
&#xD;
      Methods&#xD;
&#xD;
      This is a prospective observational study. The investigators will include 100 persons who are&#xD;
      scheduled for an elective coronary angiography.&#xD;
&#xD;
      A regular 2D-stress echocardiography according to the international guidelines will be&#xD;
      performed (incl. PLAX, SAX, 2CV, 4CV). The classification of regional wall motion abnormality&#xD;
      is carried out according to the internationally recognized standards in 16 myocardial&#xD;
      segments of the LV, with a grading of wall thickening (0 = dyskinetic, akinetic = 1, 2 =&#xD;
      hypokinetic, 3 = normal). In addition, a 3D speckle tracking is performed after data&#xD;
      transfer. To determine the functional relevance of any stenosis (reference method) a flow&#xD;
      reserve in a maximum of two coronary arteries will be performed.&#xD;
&#xD;
      Test accuracy of 2D stress echocardiography and the new 3D method for detecting a significant&#xD;
      stenosis (CFI &lt;2) are then compared.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 30, 2014</start_date>
  <completion_date type="Actual">November 30, 2016</completion_date>
  <primary_completion_date type="Actual">November 30, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Area Strain in the affected coronary artery stenosis myocardial segments (Reference: Coronary flow reserve CFR)</measure>
    <time_frame>After dobutamin-stress-echocardiography, PTCA will be performed within aprox.1-3hours</time_frame>
    <description>Area Strain (%) by Echocardiography</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area at Risk: Surface Area of site with reduced strain relative to the total LV-surface</measure>
    <time_frame>After dobutamin-stress-echocardiography, PTCA will be performed within aprox.1-3hours</time_frame>
    <description>Size of infarcted area according to the Area Strain (in % of total LV-surface)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Coronary Artery Disease</condition>
  <condition>Echocardiography, Stress</condition>
  <arm_group>
    <arm_group_label>All patients</arm_group_label>
    <description>Patients with a suspicion of coronary heart disease</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Stress-echocardiography</intervention_name>
    <description>Stress-echocardiography (incl dobutamin and atropin)</description>
    <arm_group_label>All patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        100 consecutive subjects referred to the Department of Cardiology for elective coronary&#xD;
        angiography.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Scheduled elective coronary angiography&#xD;
&#xD;
          -  Age &gt;/= 18 years&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Age &lt; 18 years&#xD;
&#xD;
          -  Acute coronary syndrome&#xD;
&#xD;
          -  Unstable angina pectoris&#xD;
&#xD;
          -  Coronary 3-vessel disease&#xD;
&#xD;
          -  Left-main artery affected&#xD;
&#xD;
          -  Situation after myocardial infarction&#xD;
&#xD;
          -  Coronary anomaly&#xD;
&#xD;
          -  Situation after coronary bypass&#xD;
&#xD;
          -  Congenital heart disease&#xD;
&#xD;
          -  Pacemaker&#xD;
&#xD;
          -  Any contraindication concerning stress-echo&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stefano de Marchi, Senior consultant</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dept. of Cardiology, University Hospital of Bern, Bern</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dept of Cardiology, Bern University Hospital</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <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>
  </reference>
  <reference>
    <citation>Doucette JW, Corl PD, Payne HM, Flynn AE, Goto M, Nassi M, Segal J. Validation of a Doppler guide wire for intravascular measurement of coronary artery flow velocity. Circulation. 1992 May;85(5):1899-911. doi: 10.1161/01.cir.85.5.1899.</citation>
    <PMID>1572046</PMID>
  </reference>
  <reference>
    <citation>Traupe T, Gloekler S, de Marchi SF, Werner GS, Seiler C. Assessment of the human coronary collateral circulation. Circulation. 2010 Sep 21;122(12):1210-20. doi: 10.1161/CIRCULATIONAHA.109.930651. No abstract available.</citation>
    <PMID>20855668</PMID>
  </reference>
  <reference>
    <citation>Meuwissen M, Siebes M, Chamuleau SA, Tijssen JG, Spaan JA, Piek JJ. Intracoronary pressure and flow velocity for hemodynamic evaluation of coronary stenoses. Expert Rev Cardiovasc Ther. 2003 Sep;1(3):471-9. doi: 10.1586/14779072.1.3.471.</citation>
    <PMID>15030274</PMID>
  </reference>
  <reference>
    <citation>Varga A, Garcia MA, Picano E; International Stress Echo Complication Registry. Safety of stress echocardiography (from the International Stress Echo Complication Registry). Am J Cardiol. 2006 Aug 15;98(4):541-3. doi: 10.1016/j.amjcard.2006.02.064. Epub 2006 Jun 28.</citation>
    <PMID>16893714</PMID>
  </reference>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>September 11, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <last_update_submitted>March 27, 2023</last_update_submitted>
  <last_update_submitted_qc>March 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Echocardiography, Stress</keyword>
  <keyword>Echocardiography, Three-Dimensional</keyword>
  <keyword>Coronary Artery Disease</keyword>
  <keyword>Fractional Flow Reserve, Myocardial</keyword>
  <keyword>Coronary Circulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
  </condition_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/NCT02240745
org study id: 039/14
secondary id: SNCTP 0761
nct id: NCT02240745
lead sponsor: 
has dmc: Yes
The investigators are going to recruit patients who have a scheduled elective coronary
      angiography and going to do a dobutamin stress echography (DSE) before the coronary
      examination. Next to a regular 2D-DSE, the investigators will perform an 3-dimensional DSE,
      incl ventriculography. In the interventional part (coronary angiography), they will measure
      each stenosis with fractional flow-reserve (FFR)and herewith graduate its stenosis severity.
Background

      Coronary heart disease is the leading cause of death worldwide. Non-invasive, radiation-free
      diagnostic needs further improvement. In this study, the investigators test the hypothesis
      that their method, which measures the myocardial deformation using 3D echocardiography is
      superior to previous ultrasound technologies with regard to diagnosis of stable coronary
      artery disease. The aim is establish an improved, non-invasive method to diagnose stable
      coronary artery disease.

      Objective

      The investigators want to investigate if a 3D-speckle-tracking is superior and more accurate
      in predicting hemodynamically significant coronary artery stenosis than predicted by 2D
      echocardiography? The reference variable for the hemodynamic significance of coronary artery
      stenosis is invasively measured by coronary flow reserve (CFR) in consideration of collateral
      flow (CFI).

      Methods

      This is a prospective observational study. The investigators will include 100 persons who are
      scheduled for an elective coronary angiography.

      A regular 2D-stress echocardiography according to the international guidelines will be
      performed (incl. PLAX, SAX, 2CV, 4CV). The classification of regional wall motion abnormality
      is carried out according to the internationally recognized standards in 16 myocardial
      segments of the LV, with a grading of wall thickening (0 = dyskinetic, akinetic = 1, 2 =
      hypokinetic, 3 = normal). In addition, a 3D speckle tracking is performed after data
      transfer. To determine the functional relevance of any stenosis (reference method) a flow
      reserve in a maximum of two coronary arteries will be performed.

      Test accuracy of 2D stress echocardiography and the new 3D method for detecting a significant
      stenosis (CFI <2) are then compared.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Area Strain in the affected coronary artery stenosis myocardial segments (Reference: Coronary flow reserve CFR)
time frame: After dobutamin-stress-echocardiography, PTCA will be performed within aprox.1-3hours
description: Area Strain (%) by Echocardiography
measure: Area at Risk: Surface Area of site with reduced strain relative to the total LV-surface
time frame: After dobutamin-stress-echocardiography, PTCA will be performed within aprox.1-3hours
description: Size of infarcted area according to the Area Strain (in % of total LV-surface)
arm group label: All patients
description: Patients with a suspicion of coronary heart disease
intervention type: Other
intervention name: Stress-echocardiography
description: Stress-echocardiography (incl dobutamin and atropin)
arm group label: All patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Stefano de Marchi, Senior consultant
role: Principal Investigator
affiliation: Dept. of Cardiology, University Hospital of Bern, Bern
facility: 
country: Switzerland
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: Doucette JW, Corl PD, Payne HM, Flynn AE, Goto M, Nassi M, Segal J. Validation of a Doppler guide wire for intravascular measurement of coronary artery flow velocity. Circulation. 1992 May;85(5):1899-911. doi: 10.1161/01.cir.85.5.1899.
PMID: 1572046
citation: Traupe T, Gloekler S, de Marchi SF, Werner GS, Seiler C. Assessment of the human coronary collateral circulation. Circulation. 2010 Sep 21;122(12):1210-20. doi: 10.1161/CIRCULATIONAHA.109.930651. No abstract available.
PMID: 20855668
citation: Meuwissen M, Siebes M, Chamuleau SA, Tijssen JG, Spaan JA, Piek JJ. Intracoronary pressure and flow velocity for hemodynamic evaluation of coronary stenoses. Expert Rev Cardiovasc Ther. 2003 Sep;1(3):471-9. doi: 10.1586/14779072.1.3.471.
PMID: 15030274
citation: Varga A, Garcia MA, Picano E; International Stress Echo Complication Registry. Safety of stress echocardiography (from the International Stress Echo Complication Registry). Am J Cardiol. 2006 Aug 15;98(4):541-3. doi: 10.1016/j.amjcard.2006.02.064. Epub 2006 Jun 28.
PMID: 16893714
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease