<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/NCT03298659</url>
  </required_header>
  <id_info>
    <org_study_id>NL60107.029.16</org_study_id>
    <nct_id>NCT03298659</nct_id>
  </id_info>
  <brief_title>iFR Guided Multi-vessel Revascularization During Percutaneous Coronary Intervention for Acute Myocardial Infarction</brief_title>
  <acronym>iMODERN</acronym>
  <official_title>Instantaneous Wave-free Ratio Guided Multi-vessel revascularizatiOn During Percutaneous Coronary intervEntion for Acute myocaRdial iNfarction (iMODERN)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Radboud University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Volcano Europe BVBA/SPRL</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Biotronik AG</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Stichting Life Sciences &amp; Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Duke Cardiovascular Magnetic Resonance Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Radboud University Medical Center</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      In patients with acute ST-elevation myocardial infarction (STEMI), 40-60% have multi-vessel&#xD;
      disease with an increased cardiovascular morbidity and mortality. Although it is not&#xD;
      recommended to revascularize noninfarct lesions during the acute intervention, recent&#xD;
      investigations suggest the opposite and show improved outcome after direct revascularization&#xD;
      of noninfarct lesions. It is undesirable to risk procedure-related complications by treating&#xD;
      noninfarct lesions without impaired flow. It is currently unknown whether pressure guided&#xD;
      revascularization of noninfarct lesions in the acute phase improves outcome compared to the&#xD;
      current guidelines.&#xD;
&#xD;
      The iMODERN trial aims to compare an iFR-guided intervention of noninfarct lesions during the&#xD;
      acute intervention with a deferred stress perfusion CMR-guided strategy during the outpatient&#xD;
      follow-up, to determine the optimal therapeutic approach for STEMI patients with multivessel&#xD;
      lesions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study design:&#xD;
&#xD;
      The study is a prospective, randomized controlled, multicentre study.&#xD;
&#xD;
      Study population:&#xD;
&#xD;
      The research population will be recruited from the general patient population presenting with&#xD;
      an acute STEMI. Patients treated with successful primary PCI and one or more additional&#xD;
      significant coronary lesions in another coronary artery will be enrolled in the study. A&#xD;
      total of 1,146 consecutive patients will be included.&#xD;
&#xD;
      Intervention:&#xD;
&#xD;
      The patients will be randomized 1:1, to (A) an active treatment arm with complete, iFR-guided&#xD;
      revascularization of every noninfarct coronary lesion &gt;50% and iFR ≤0.89; (B) a deferred&#xD;
      treatment arm, in which patients will undergo an adenosine stress perfusion CMR scan within 6&#xD;
      weeks after STEMI, with revascularization of the noninfarct coronary lesions with associated&#xD;
      perfusion defects.&#xD;
&#xD;
      Main study parameters/endpoints:&#xD;
&#xD;
      The primary end point consists of a combined outcome, including all-cause death, recurrent MI&#xD;
      and hospitalization for heart failure at 3 years follow-up.&#xD;
&#xD;
      Duration:&#xD;
&#xD;
      Anticipated recruitment is 2 years. Follow-up will be performed at 6 months, 12 months, 3&#xD;
      years and 5 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 21, 2017</start_date>
  <completion_date type="Anticipated">February 23, 2027</completion_date>
  <primary_completion_date type="Actual">February 23, 2022</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>
    <intervention_model_description>1:1 randomization to (A) an active treatment arm with complete, iFR-guided revascularization of every noninfarct coronary lesion &gt;50% and iFR ≤0.89; or (B) a deferred treatment arm, in which patients will undergo an adenosine stress perfusion CMR scan within 6 weeks after STEMI, with revascularization of the noninfarct coronary lesions with associated perfusion defects.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Composite end point of Major Adverse Cardiac Events</measure>
    <time_frame>3 years</time_frame>
    <description>All-cause death, recurrent myocardial infarction and hospitalization for heart failure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>All cause mortality</measure>
    <time_frame>6 and 12 months, 3 and 5 years</time_frame>
    <description>All cause mortality at 6 and 12 months, 3 and 5 years</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular mortality</measure>
    <time_frame>6 and 12 months, 3 and 5 years</time_frame>
    <description>Cardiovascular mortality at 6 and 12 months, 3 and 5 years</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Myocardial infarction</measure>
    <time_frame>6 and 12 months, 3 and 5 years</time_frame>
    <description>Myocardial infarction at 6 and 12 months, 3 and 5 years</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cerebral events</measure>
    <time_frame>6 and 12 months, 3 and 5 years</time_frame>
    <description>Stroke and transient ischemic attack</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major bleeding</measure>
    <time_frame>6 months</time_frame>
    <description>Haemorrhagic complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Unstable angina</measure>
    <time_frame>6 and 12 months, 3 and 5 years</time_frame>
    <description>Unstable angina including ECG-changes at 6 and 12 months, 3 and 5 years</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Coronary angiography</measure>
    <time_frame>6 and 12 months, 3 and 5 years</time_frame>
    <description>Coronary angiography at 6 and 12 months, 3 and 5 years</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Revascularization</measure>
    <time_frame>6 and 12 months, 3 and 5 years</time_frame>
    <description>Any revascularization at 6 and 12 months, 3 and 5 years</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target lesion failure</measure>
    <time_frame>6 and 12 months, 3 and 5 years</time_frame>
    <description>Failure and/or revascularization by percutaneous or surgical methods of the target lesion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stent thrombosis</measure>
    <time_frame>6 and 12 months, 3 and 5 years</time_frame>
    <description>Stent thrombosis at 6 and 12 months, 3 and 5 years</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost effectiveness analysis</measure>
    <time_frame>6 and 12 months, 3 and 5 years</time_frame>
    <description>Costs related to complete, iFR-guided revascularization versus CMR-guided treatment, including cost utility analysisfrom a societal perspective with the costs per prevented cardiac eventand the costs per QALY as the respective primary health economic outcomes (using a quality of life questionnaire and a health care resource use questionnaire)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>6 and 12 months, 3 and 5 years</time_frame>
    <description>Quality of life questionnaires, i.e. SAQ, EQ-5D-5L and Minnesota heart failure questionnaire, at 6 and 12 months, 3 and 5 years</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1146</enrollment>
  <condition>Acute Myocardial Infarction</condition>
  <condition>Multi Vessel Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Active iFR-guided revascularization</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Decision to treat the nonculprit coronary stenosis if there is a significant pressure drop over the stenosis, as measured by intracoronary iFR assessment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Deferred CMR-guided revascularization</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Decision to treat the nonculprit coronary stenosis if perfusion defect visible in corresponding coronary territory as visualized on stress perfusion CMR imaging</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>iFR</intervention_name>
    <description>Treatment guided by instantaneous wave-free ratio</description>
    <arm_group_label>Active iFR-guided revascularization</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>CMR</intervention_name>
    <description>Treatment guided by stress perfusion CMR</description>
    <arm_group_label>Deferred CMR-guided revascularization</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical presentation of STEMI and successful primary PCI within 12 hours from onset&#xD;
             of symptoms.&#xD;
&#xD;
          -  One or more other, noninfarct coronary artery lesions of &gt;50% stenosis and feasible to&#xD;
             be revascularized (i.e. minimal diameter 2mm).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of myocardial infarction.&#xD;
&#xD;
          -  Hemodynamic instability, respiratory failure, Kilips class ≥III.&#xD;
&#xD;
          -  Known GFR&lt;30 ml/min.&#xD;
&#xD;
          -  Known contra-indications for stress CMR (e.g.: severe claustrophobia, metal implants,&#xD;
             severe renal failure, severe astma).&#xD;
&#xD;
          -  Refusal or inability to provide informed consent.&#xD;
&#xD;
          -  Life expectancy due to noncardiovascular co-morbidity of less than 12 months.&#xD;
&#xD;
          -  Chronic total occlusion.&#xD;
&#xD;
          -  Left main stem stenosis (&gt;50%).&#xD;
&#xD;
          -  Residual noninfarct lesion in infarct coronary artery.&#xD;
&#xD;
          -  Complex (e.g. bifurcation) noninfarct target lesions.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Robin Nijveldt, MD</last_name>
    <phone>+31243614533</phone>
    <email>Robin@Nijveldt.net</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Stefaan Van der Meulen, MSc</last_name>
    <phone>+32477984154</phone>
    <email>svandermeulen@syntactx.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Radboudumc</name>
      <address>
        <city>Nijmegen</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Robin Nijveldt, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 2, 2017</study_first_posted>
  <last_update_submitted>March 14, 2022</last_update_submitted>
  <last_update_submitted_qc>March 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03298659
org study id: NL60107.029.16
nct id: NCT03298659
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
In patients with acute ST-elevation myocardial infarction (STEMI), 40-60% have multi-vessel
      disease with an increased cardiovascular morbidity and mortality. Although it is not
      recommended to revascularize noninfarct lesions during the acute intervention, recent
      investigations suggest the opposite and show improved outcome after direct revascularization
      of noninfarct lesions. It is undesirable to risk procedure-related complications by treating
      noninfarct lesions without impaired flow. It is currently unknown whether pressure guided
      revascularization of noninfarct lesions in the acute phase improves outcome compared to the
      current guidelines.

      The iMODERN trial aims to compare an iFR-guided intervention of noninfarct lesions during the
      acute intervention with a deferred stress perfusion CMR-guided strategy during the outpatient
      follow-up, to determine the optimal therapeutic approach for STEMI patients with multivessel
      lesions.
Study design:

      The study is a prospective, randomized controlled, multicentre study.

      Study population:

      The research population will be recruited from the general patient population presenting with
      an acute STEMI. Patients treated with successful primary PCI and one or more additional
      significant coronary lesions in another coronary artery will be enrolled in the study. A
      total of 1,146 consecutive patients will be included.

      Intervention:

      The patients will be randomized 1:1, to (A) an active treatment arm with complete, iFR-guided
      revascularization of every noninfarct coronary lesion >50% and iFR ≤0.89; (B) a deferred
      treatment arm, in which patients will undergo an adenosine stress perfusion CMR scan within 6
      weeks after STEMI, with revascularization of the noninfarct coronary lesions with associated
      perfusion defects.

      Main study parameters/endpoints:

      The primary end point consists of a combined outcome, including all-cause death, recurrent MI
      and hospitalization for heart failure at 3 years follow-up.

      Duration:

      Anticipated recruitment is 2 years. Follow-up will be performed at 6 months, 12 months, 3
      years and 5 years.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 1:1 randomization to (A) an active treatment arm with complete, iFR-guided revascularization of every noninfarct coronary lesion >50% and iFR ≤0.89; or (B) a deferred treatment arm, in which patients will undergo an adenosine stress perfusion CMR scan within 6 weeks after STEMI, with revascularization of the noninfarct coronary lesions with associated perfusion defects.
primary purpose: Diagnostic
masking: None (Open Label)
measure: Composite end point of Major Adverse Cardiac Events
time frame: 3 years
description: All-cause death, recurrent myocardial infarction and hospitalization for heart failure
measure: All cause mortality
time frame: 6 and 12 months, 3 and 5 years
description: All cause mortality at 6 and 12 months, 3 and 5 years
measure: Cardiovascular mortality
time frame: 6 and 12 months, 3 and 5 years
description: Cardiovascular mortality at 6 and 12 months, 3 and 5 years
measure: Myocardial infarction
time frame: 6 and 12 months, 3 and 5 years
description: Myocardial infarction at 6 and 12 months, 3 and 5 years
measure: Cerebral events
time frame: 6 and 12 months, 3 and 5 years
description: Stroke and transient ischemic attack
measure: Major bleeding
time frame: 6 months
description: Haemorrhagic complications
measure: Unstable angina
time frame: 6 and 12 months, 3 and 5 years
description: Unstable angina including ECG-changes at 6 and 12 months, 3 and 5 years
measure: Coronary angiography
time frame: 6 and 12 months, 3 and 5 years
description: Coronary angiography at 6 and 12 months, 3 and 5 years
measure: Revascularization
time frame: 6 and 12 months, 3 and 5 years
description: Any revascularization at 6 and 12 months, 3 and 5 years
measure: Target lesion failure
time frame: 6 and 12 months, 3 and 5 years
description: Failure and/or revascularization by percutaneous or surgical methods of the target lesion
measure: Stent thrombosis
time frame: 6 and 12 months, 3 and 5 years
description: Stent thrombosis at 6 and 12 months, 3 and 5 years
measure: Cost effectiveness analysis
time frame: 6 and 12 months, 3 and 5 years
description: Costs related to complete, iFR-guided revascularization versus CMR-guided treatment, including cost utility analysisfrom a societal perspective with the costs per prevented cardiac eventand the costs per QALY as the respective primary health economic outcomes (using a quality of life questionnaire and a health care resource use questionnaire)
measure: Quality of life
time frame: 6 and 12 months, 3 and 5 years
description: Quality of life questionnaires, i.e. SAQ, EQ-5D-5L and Minnesota heart failure questionnaire, at 6 and 12 months, 3 and 5 years
arm group label: Active iFR-guided revascularization
arm group type: Experimental
description: Decision to treat the nonculprit coronary stenosis if there is a significant pressure drop over the stenosis, as measured by intracoronary iFR assessment
arm group label: Deferred CMR-guided revascularization
arm group type: Active Comparator
description: Decision to treat the nonculprit coronary stenosis if perfusion defect visible in corresponding coronary territory as visualized on stress perfusion CMR imaging
intervention type: Diagnostic Test
intervention name: iFR
description: Treatment guided by instantaneous wave-free ratio
arm group label: Active iFR-guided revascularization
intervention type: Diagnostic Test
intervention name: CMR
description: Treatment guided by stress perfusion CMR
arm group label: Deferred CMR-guided revascularization
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Robin Nijveldt, MD
phone: +31243614533
email: Robin@Nijveldt.net
last name: Stefaan Van der Meulen, MSc
phone: +32477984154
email: svandermeulen@syntactx.com
facility: 
status: Recruiting
contact: 
country: Netherlands
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Myocardial Infarction
mesh term: Infarction
sharing ipd: No