<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/NCT03004703</url>
  </required_header>
  <id_info>
    <org_study_id>ASSAIL-MI 2.0</org_study_id>
    <secondary_id>2016-002581-31</secondary_id>
    <nct_id>NCT03004703</nct_id>
  </id_info>
  <brief_title>ASSessing the Effect of Anti-IL-6 Treatment in Myocardial Infarction: The ASSAIL-MI Trial</brief_title>
  <acronym>ASSAIL-MI</acronym>
  <official_title>ASSessing the Effect of Anti-IL-6 Treatment in Myocardial Infarction: The ASSAIL-MI Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oslo University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>St. Olavs Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>South-Eastern Norway Regional Health Authority</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Oslo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Norwegian University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Oslo University Hospital</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 main goal of this study is to evaluate the ability of a single administration of&#xD;
      tocilizumab to reduce myocardial damage in patients presenting with an acute ST-segment&#xD;
      elevation myocardial infarction (STEMI). Secondary objectives are to assess the impact of&#xD;
      treatment on: (i) final infarct size, (ii) left ventricular size and function, (iii)&#xD;
      inflammation, (iv) extracellular matrix remodeling, (v) lipid parameters, (vi) platelet&#xD;
      activation and additional pro- and anti-thrombotic parameters, and (vii) study drug safety&#xD;
      and tolerability.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Myocardial infarction (MI) is a major contributor to morbidity and mortality in the Western&#xD;
      world. The main determinant of death and complications is infarct size, and limitation of the&#xD;
      infarct size has therefore been an important objective for strategies to improve outcome. In&#xD;
      patients presenting with an acute ST segment elevation myocardial infarction (STEMI), urgent&#xD;
      myocardial reperfusion with percutaneous coronary intervention (PCI) is the most effective&#xD;
      treatment to this end. However, despite PCI, the morbidity and mortality in patients with&#xD;
      STEMI remain substantial. This fact suggests that other, adjuvant strategies are required to&#xD;
      reduce infarct size and improve outcome. The inflammatory cytokine interleukin (IL)-6 is an&#xD;
      important mediator of plaque destabilisation and rupture in acute coronary syndrome (ACS) and&#xD;
      may contribute to the ischemia-reperfusion injury succeeding revascularisation. Experimental&#xD;
      studies suggest that IL-6 inhibition can limit infarct size through anti-inflammatory&#xD;
      mechanisms.(ref)&#xD;
&#xD;
      The investigators recently conducted a double blind, placebo controlled trial in 117 patients&#xD;
      with non-ST segment elevation myocardial infarction (NSTEMI) who presented within 72 hour&#xD;
      after the onset of chest pain. In this study, a single, intravenous dose of the IL-6&#xD;
      antagonist tocilizumab reduced the inflammatory activity by more than 50% in the days&#xD;
      subsequent to the intervention. Importantly, tocilizumab also reduced troponin T (TnT)&#xD;
      levels, suggesting that patients receiving tocilizumab sustained less myocardial damage than&#xD;
      patients who received placebo.1&#xD;
&#xD;
      Interleukin-6 inhibition might limit infarct size through reduced myocardial inflammation,&#xD;
      but theoretically, it could also inhibit the repair process within the injured area. While&#xD;
      the recent study suggests that IL-6 inhibition has largely favourable effects in NSTEMI, it&#xD;
      remains to be seen if similar, beneficial effects can be obtained in patients with STEMI. On&#xD;
      this background, the investigators want to investigate the effect of tocilizumab in patients&#xD;
      with acute STEMI. The postulate is that a single dose of tocilizumab (RoActemra®) will have&#xD;
      favourable effects on infarct size, as assessed by markers of myocardial necrosis and cardiac&#xD;
      magnetic resonance imaging (CMR), without negative consequences for the repair process in&#xD;
      these patients. The hypothesis will be tested in a randomised, double blind, placebo&#xD;
      controlled trial comprising 200 patients with acute STEMI.&#xD;
&#xD;
      This is a phase 2 study on a new and exciting anti-inflammatory strategy in cardiovascular&#xD;
      disease. It will be conducted at three experienced, high volume centres in Norway, and will&#xD;
      target new and yet unmodified mechanisms during myocardial infarction. The ambition is to&#xD;
      improve the prognosis of patients with ACS, with potential to change clinical practice.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 16, 2017</start_date>
  <completion_date type="Actual">February 10, 2021</completion_date>
  <primary_completion_date type="Actual">February 19, 2020</primary_completion_date>
  <phase>Phase 2</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The primary endpoint will be the between-group difference in the myocardial salvage index as measured in the acute phase by cardiac magnetic resonance (CMR) imaging with late gadolinium enhancement (LGE).</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The between-group difference in the AUC for Troponin T (TnT) during index hospitalisation</measure>
    <time_frame>24 -72 hours after randomisation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The extent of microvascular obstruction as measured by CMR after 3 - 7 days</measure>
    <time_frame>3 - 7 days after randomisation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Final infarct size as measured by CMR 6 months after randomisation</measure>
    <time_frame>6 months after randomisation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Left ventricular size as assessed by CMR 6 months after randomisation</measure>
    <time_frame>6 months after randomisation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baseline-adjusted NT-proBNP at 6 months after randomisation</measure>
    <time_frame>6 months after randomisation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The AUC of Creatine Kinase-MB (CK-MB) during index hospitalisation</measure>
    <time_frame>24-72 hours after randomisation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The AUC of C-reactive protein (CRP) during index hospitalisation</measure>
    <time_frame>24-72 hours after randomisation</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Coronary Disease</condition>
  <condition>Myocardial Infarction</condition>
  <arm_group>
    <arm_group_label>Active drug</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tocilizumab, 20 mg/ml; 14 ml (280 mg) dissolved in 100 ml NaCl 0.9 % i.v. once.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Sodium chloride 0.9%; 100 ml i.v. once.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tocilizumab</intervention_name>
    <description>Active drug: Tocilizumab, 20 mg/ml; 14 ml (280 mg) dissolved in 100 ml NaCl 0.9 % i.v. once.</description>
    <arm_group_label>Active drug</arm_group_label>
    <other_name>RoActemra®,</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sodium chloride 0.9%</intervention_name>
    <description>Placebo: Sodium chloride 0.9%; 100 ml i.v. once.</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>NaCl 0.9%</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients will be screened for eligibility upon admittance due to acute STEMI at either&#xD;
        participating site. All of the following conditions must apply to the prospective patient&#xD;
        at screening prior to receiving study agent:&#xD;
&#xD;
          -  New ST elevation at the J-point in two contiguous leads (cut-points: 0.2mV in men and&#xD;
             &gt;0.15 mV in women in leads V2-V3 and/or &gt;0.1 mV in other leads) in combination with&#xD;
             symptoms consistent with acute MI.&#xD;
&#xD;
          -  Presentation within 6 hours of chest pain.&#xD;
&#xD;
          -  Indication for urgent coronary angiography with intent to reperfuse presumed occluded&#xD;
             vessel.&#xD;
&#xD;
          -  Age between 18 and 80 years.&#xD;
&#xD;
          -  Informed consent obtained and documented according to ICH/GCP, and national/local&#xD;
             regulations.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients will be excluded from the study if they meet any of the following criteria:&#xD;
&#xD;
          -  NSTEMI (non-ST segment elevation in ECG).&#xD;
&#xD;
          -  Left bundle branch block in ECG&#xD;
&#xD;
          -  History of previous MI&#xD;
&#xD;
          -  Cardiogenic shock.&#xD;
&#xD;
          -  Fibrinolytic therapy within 72 hours prior to admission.&#xD;
&#xD;
          -  Cardiac arrest / ventricular fibrillation.&#xD;
&#xD;
          -  History of severe renal failure with estimated glomerular filtration rate &lt; 30&#xD;
             ml/minutes.&#xD;
&#xD;
          -  Known, current liver disease&#xD;
&#xD;
          -  History of concurrent inflammatory, biliary obstructive or malignant disease&#xD;
&#xD;
          -  A history of chronic or concurrent infectious disease, including a history of HIV,&#xD;
             tuberculosis, or hepatitis B or C.&#xD;
&#xD;
          -  Known, uncontrolled lower gastrointestinal (GI) disease such as diverticulitis,&#xD;
             Crohn's disease, ulcerative colitis, or other symptomatic lower GI conditions that&#xD;
             could predispose to GI perforations&#xD;
&#xD;
          -  Major surgery within 8 weeks prior or after baseline&#xD;
&#xD;
          -  History of central nervous system demyelinating or seizure disorders&#xD;
&#xD;
          -  History of primary or secondary immunodeficiency&#xD;
&#xD;
          -  Treatment with immunosuppressants other than low dose corticosteroids (equivalent to 5&#xD;
             mg of prednisone or less) at the time of randomisation&#xD;
&#xD;
          -  Immunization with a live/attenuated vaccine within 4 weeks prior to baseline&#xD;
&#xD;
          -  History of severe allergic or anaphylactic reactions to humanized or murine monoclonal&#xD;
             antibodies or to tocilizumab&#xD;
&#xD;
          -  Other contraindications to study medication&#xD;
&#xD;
          -  Pregnancy, possible pregnancy or breast-feeding - women of child-bearing potential or&#xD;
             breastfeeding mothers cannot participate. A woman is considered of childbearing&#xD;
             potential following menarche and until becoming post-menopausal unless permanently&#xD;
             sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy&#xD;
             and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12&#xD;
             months without an alternative medical cause.&#xD;
&#xD;
          -  Contraindications to CMR (pacemaker, CRT, ICD, certain ferromagnetic implants, severe&#xD;
             claustrophobia, allergy to contrast medium).&#xD;
&#xD;
          -  Any condition/circumstances believed to interfere with the ability to comply with&#xD;
             protocol.&#xD;
&#xD;
          -  Any reason why, in the opinion of the investigator, the patient should not&#xD;
             participate.&#xD;
&#xD;
          -  Failure to obtain written, informed consent by patient or next of kin, for instance in&#xD;
             case of patient death after consent has been provided in oral.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lars Gullestad, Professor, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oslo University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bjørn Bendz, Associate Professor, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Oslo University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Pål Aukrust, Professor, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Oslo University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Svend Aakhus, Professor, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Oslo University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rune Wiseth, Professor, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>St. Olavs Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jan Kristian Damaas, Professor, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>St. Olavs Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Geir Øystein Andersen, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Oslo University Hospital, Ullevål</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nils Einar Kløw, Professor, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Oslo University Hospital, Ullevål</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Anders Opdahl, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Oslo University Hospital, Ullevål</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Oslo University Hospital, Rikshospitalet</name>
      <address>
        <city>Oslo</city>
        <zip>0424</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oslo University Hospital, Ullevål</name>
      <address>
        <city>Oslo</city>
        <zip>0424</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Olav Hospital</name>
      <address>
        <city>Trondheim</city>
        <zip>7006</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
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  <reference>
    <citation>Lunde K, Solheim S, Aakhus S, Arnesen H, Abdelnoor M, Egeland T, Endresen K, Ilebekk A, Mangschau A, Fjeld JG, Smith HJ, Taraldsrud E, Grogaard HK, Bjornerheim R, Brekke M, Muller C, Hopp E, Ragnarsson A, Brinchmann JE, Forfang K. Intracoronary injection of mononuclear bone marrow cells in acute myocardial infarction. N Engl J Med. 2006 Sep 21;355(12):1199-209. doi: 10.1056/NEJMoa055706.</citation>
    <PMID>16990383</PMID>
  </reference>
  <reference>
    <citation>Gibbons RJ, Valeti US, Araoz PA, Jaffe AS. The quantification of infarct size. J Am Coll Cardiol. 2004 Oct 19;44(8):1533-42. doi: 10.1016/j.jacc.2004.06.071.</citation>
    <PMID>15489082</PMID>
  </reference>
  <reference>
    <citation>Engblom H, Heiberg E, Erlinge D, Jensen SE, Nordrehaug JE, Dubois-Rande JL, Halvorsen S, Hoffmann P, Koul S, Carlsson M, Atar D, Arheden H. Sample Size in Clinical Cardioprotection Trials Using Myocardial Salvage Index, Infarct Size, or Biochemical Markers as Endpoint. J Am Heart Assoc. 2016 Mar 9;5(3):e002708. doi: 10.1161/JAHA.115.002708.</citation>
    <PMID>26961520</PMID>
  </reference>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>December 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <last_update_submitted>February 28, 2021</last_update_submitted>
  <last_update_submitted_qc>February 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oslo University Hospital</investigator_affiliation>
    <investigator_full_name>Lars Gullestad</investigator_full_name>
    <investigator_title>Profesor</investigator_title>
  </responsible_party>
  <keyword>Interleukin 6</keyword>
  <keyword>Tocilizumab</keyword>
  <keyword>Acute coronary syndrome</keyword>
  <keyword>STEMI</keyword>
  <keyword>Inflammation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Undecided</ipd_description>
  </patient_data>
  <!-- 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/NCT03004703
org study id: ASSAIL-MI 2.0
secondary id: 2016-002581-31
nct id: NCT03004703
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The main goal of this study is to evaluate the ability of a single administration of
      tocilizumab to reduce myocardial damage in patients presenting with an acute ST-segment
      elevation myocardial infarction (STEMI). Secondary objectives are to assess the impact of
      treatment on: (i) final infarct size, (ii) left ventricular size and function, (iii)
      inflammation, (iv) extracellular matrix remodeling, (v) lipid parameters, (vi) platelet
      activation and additional pro- and anti-thrombotic parameters, and (vii) study drug safety
      and tolerability.
Myocardial infarction (MI) is a major contributor to morbidity and mortality in the Western
      world. The main determinant of death and complications is infarct size, and limitation of the
      infarct size has therefore been an important objective for strategies to improve outcome. In
      patients presenting with an acute ST segment elevation myocardial infarction (STEMI), urgent
      myocardial reperfusion with percutaneous coronary intervention (PCI) is the most effective
      treatment to this end. However, despite PCI, the morbidity and mortality in patients with
      STEMI remain substantial. This fact suggests that other, adjuvant strategies are required to
      reduce infarct size and improve outcome. The inflammatory cytokine interleukin (IL)-6 is an
      important mediator of plaque destabilisation and rupture in acute coronary syndrome (ACS) and
      may contribute to the ischemia-reperfusion injury succeeding revascularisation. Experimental
      studies suggest that IL-6 inhibition can limit infarct size through anti-inflammatory
      mechanisms.(ref)

      The investigators recently conducted a double blind, placebo controlled trial in 117 patients
      with non-ST segment elevation myocardial infarction (NSTEMI) who presented within 72 hour
      after the onset of chest pain. In this study, a single, intravenous dose of the IL-6
      antagonist tocilizumab reduced the inflammatory activity by more than 50% in the days
      subsequent to the intervention. Importantly, tocilizumab also reduced troponin T (TnT)
      levels, suggesting that patients receiving tocilizumab sustained less myocardial damage than
      patients who received placebo.1

      Interleukin-6 inhibition might limit infarct size through reduced myocardial inflammation,
      but theoretically, it could also inhibit the repair process within the injured area. While
      the recent study suggests that IL-6 inhibition has largely favourable effects in NSTEMI, it
      remains to be seen if similar, beneficial effects can be obtained in patients with STEMI. On
      this background, the investigators want to investigate the effect of tocilizumab in patients
      with acute STEMI. The postulate is that a single dose of tocilizumab (RoActemra®) will have
      favourable effects on infarct size, as assessed by markers of myocardial necrosis and cardiac
      magnetic resonance imaging (CMR), without negative consequences for the repair process in
      these patients. The hypothesis will be tested in a randomised, double blind, placebo
      controlled trial comprising 200 patients with acute STEMI.

      This is a phase 2 study on a new and exciting anti-inflammatory strategy in cardiovascular
      disease. It will be conducted at three experienced, high volume centres in Norway, and will
      target new and yet unmodified mechanisms during myocardial infarction. The ambition is to
      improve the prognosis of patients with ACS, with potential to change clinical practice.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The primary endpoint will be the between-group difference in the myocardial salvage index as measured in the acute phase by cardiac magnetic resonance (CMR) imaging with late gadolinium enhancement (LGE).
time frame: 6 months
measure: The between-group difference in the AUC for Troponin T (TnT) during index hospitalisation
time frame: 24 -72 hours after randomisation
measure: The extent of microvascular obstruction as measured by CMR after 3 - 7 days
time frame: 3 - 7 days after randomisation
measure: Final infarct size as measured by CMR 6 months after randomisation
time frame: 6 months after randomisation
measure: Left ventricular size as assessed by CMR 6 months after randomisation
time frame: 6 months after randomisation
measure: Baseline-adjusted NT-proBNP at 6 months after randomisation
time frame: 6 months after randomisation
measure: The AUC of Creatine Kinase-MB (CK-MB) during index hospitalisation
time frame: 24-72 hours after randomisation
measure: The AUC of C-reactive protein (CRP) during index hospitalisation
time frame: 24-72 hours after randomisation
arm group label: Active drug
arm group type: Experimental
description: Tocilizumab, 20 mg/ml; 14 ml (280 mg) dissolved in 100 ml NaCl 0.9 % i.v. once.
arm group label: Placebo
arm group type: Placebo Comparator
description: Sodium chloride 0.9%; 100 ml i.v. once.
intervention type: Drug
intervention name: Tocilizumab
description: Active drug: Tocilizumab, 20 mg/ml; 14 ml (280 mg) dissolved in 100 ml NaCl 0.9 % i.v. once.
arm group label: Active drug
other name: RoActemra®,
intervention type: Drug
intervention name: Sodium chloride 0.9%
description: Placebo: Sodium chloride 0.9%; 100 ml i.v. once.
arm group label: Placebo
other name: NaCl 0.9%
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Lars Gullestad, Professor, MD, PhD
role: Principal Investigator
affiliation: Oslo University Hospital
last name: Bjørn Bendz, Associate Professor, MD, PhD
role: Study Chair
affiliation: Oslo University Hospital
last name: Pål Aukrust, Professor, MD, PhD
role: Study Chair
affiliation: Oslo University Hospital
last name: Svend Aakhus, Professor, MD, PhD
role: Study Chair
affiliation: Oslo University Hospital
last name: Rune Wiseth, Professor, MD, PhD
role: Study Chair
affiliation: St. Olavs Hospital
last name: Jan Kristian Damaas, Professor, MD, PhD
role: Study Chair
affiliation: St. Olavs Hospital
last name: Geir Øystein Andersen, MD, PhD
role: Study Chair
affiliation: Oslo University Hospital, Ullevål
last name: Nils Einar Kløw, Professor, MD, PhD
role: Study Chair
affiliation: Oslo University Hospital, Ullevål
last name: Anders Opdahl, MD, PhD
role: Study Chair
affiliation: Oslo University Hospital, Ullevål
facility: 
facility: 
facility: 
country: Norway
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PMID: 27412895
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PMID: 25236513
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PMID: 16990383
citation: Gibbons RJ, Valeti US, Araoz PA, Jaffe AS. The quantification of infarct size. J Am Coll Cardiol. 2004 Oct 19;44(8):1533-42. doi: 10.1016/j.jacc.2004.06.071.
PMID: 15489082
citation: Engblom H, Heiberg E, Erlinge D, Jensen SE, Nordrehaug JE, Dubois-Rande JL, Halvorsen S, Hoffmann P, Koul S, Carlsson M, Atar D, Arheden H. Sample Size in Clinical Cardioprotection Trials Using Myocardial Salvage Index, Infarct Size, or Biochemical Markers as Endpoint. J Am Heart Assoc. 2016 Mar 9;5(3):e002708. doi: 10.1161/JAHA.115.002708.
PMID: 26961520
responsible party type: Principal Investigator
investigator affiliation: Oslo University Hospital
investigator full name: Lars Gullestad
investigator title: Profesor
mesh term: Myocardial Infarction
mesh term: Coronary Disease
mesh term: Infarction
sharing ipd: Undecided
ipd description: Undecided