Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

iFR Guided Multi-vessel Revascularization During Percutaneous Coronary Intervention for Acute Myocardial Infarction (iMODERN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03298659
Recruitment Status : Recruiting
First Posted : October 2, 2017
Last Update Posted : May 2, 2019
Sponsor:
Collaborators:
Volcano Europe BVBA/SPRL
Biotronik AG
Stichting Life Sciences & Health
Duke Cardiovascular Magnetic Resonance Center
Information provided by (Responsible Party):
Radboud University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Multi Vessel Coronary Artery Disease Diagnostic Test: iFR Diagnostic Test: CMR Not Applicable

Detailed Description:

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 12 months follow-up.

Duration:

Anticipated recruitment is 2 years. Follow-up will be performed at 6 months, 12 months, 3 years and 5 years.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1146 participants
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.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Instantaneous Wave-free Ratio Guided Multi-vessel revascularizatiOn During Percutaneous Coronary intervEntion for Acute myocaRdial iNfarction (iMODERN)
Actual Study Start Date : December 21, 2017
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Experimental: Active iFR-guided revascularization
Decision to treat the nonculprit coronary stenosis if there is a significant pressure drop over the stenosis, as measured by intracoronary iFR assessment
Diagnostic Test: iFR
Treatment guided by instantaneous wave-free ratio

Active Comparator: Deferred CMR-guided revascularization
Decision to treat the nonculprit coronary stenosis if perfusion defect visible in corresponding coronary territory as visualized on stress perfusion CMR imaging
Diagnostic Test: CMR
Treatment guided by stress perfusion CMR




Primary Outcome Measures :
  1. Composite end point of Major Adverse Cardiac Events [ Time Frame: 12 months ]
    All-cause death, recurrent myocardial infarction and hospitalization for heart failure


Secondary Outcome Measures :
  1. All cause mortality [ Time Frame: 6 and 12 months, 3 and 5 years ]
    All cause mortality at 6 and 12 months, 3 and 5 years

  2. Cardiovascular mortality [ Time Frame: 6 and 12 months, 3 and 5 years ]
    Cardiovascular mortality at 6 and 12 months, 3 and 5 years

  3. Myocardial infarction [ Time Frame: 6 and 12 months, 3 and 5 years ]
    Myocardial infarction at 6 and 12 months, 3 and 5 years

  4. Cerebral events [ Time Frame: 6 and 12 months, 3 and 5 years ]
    Stroke and transient ischemic attack

  5. Major bleeding [ Time Frame: 6 months ]
    Haemorrhagic complications

  6. Unstable angina [ Time Frame: 6 and 12 months, 3 and 5 years ]
    Unstable angina including ECG-changes at 6 and 12 months, 3 and 5 years

  7. Coronary angiography [ Time Frame: 6 and 12 months, 3 and 5 years ]
    Coronary angiography at 6 and 12 months, 3 and 5 years

  8. Revascularization [ Time Frame: 6 and 12 months, 3 and 5 years ]
    Any revascularization at 6 and 12 months, 3 and 5 years

  9. Target lesion failure [ Time Frame: 6 and 12 months, 3 and 5 years ]
    Failure and/or revascularization by percutaneous or surgical methods of the target lesion

  10. Stent thrombosis [ Time Frame: 6 and 12 months, 3 and 5 years ]
    Stent thrombosis at 6 and 12 months, 3 and 5 years

  11. Cost effectiveness analysis [ Time Frame: 6 and 12 months, 3 and 5 years ]
    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)

  12. Quality of life [ Time Frame: 6 and 12 months, 3 and 5 years ]
    Quality of life questionnaires, i.e. SAQ, EQ-5D-5L and Minnesota heart failure questionnaire, at 6 and 12 months, 3 and 5 years



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical presentation of STEMI and successful primary PCI within 12 hours from onset of symptoms.
  • One or more other, noninfarct coronary artery lesions of >50% stenosis and feasible to be revascularized (i.e. minimal diameter 2mm).

Exclusion Criteria:

  • History of myocardial infarction.
  • Hemodynamic instability, respiratory failure, Kilips class ≥III.
  • Known GFR<30 ml/min.
  • Known contra-indications for stress CMR (e.g.: severe claustrophobia, metal implants, severe renal failure, severe astma).
  • Refusal or inability to provide informed consent.
  • Life expectancy due to noncardiovascular co-morbidity of less than 12 months.
  • Chronic total occlusion.
  • Left main stem stenosis (>50%).
  • Residual noninfarct lesion in infarct coronary artery.
  • Complex (e.g. bifurcation) noninfarct target lesions.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03298659


Contacts
Layout table for location contacts
Contact: Robin Nijveldt, MD +31243614533 Robin@Nijveldt.net
Contact: Stefaan Van der Meulen, MSc +32477984154 svandermeulen@syntactx.com

Locations
Layout table for location information
Netherlands
Radboudumc Recruiting
Nijmegen, Netherlands
Contact: Robin Nijveldt, MD         
Sponsors and Collaborators
Radboud University
Volcano Europe BVBA/SPRL
Biotronik AG
Stichting Life Sciences & Health
Duke Cardiovascular Magnetic Resonance Center

Layout table for additonal information
Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT03298659    
Other Study ID Numbers: NL60107.029.16
First Posted: October 2, 2017    Key Record Dates
Last Update Posted: May 2, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronary Artery Disease
Myocardial Infarction
Infarction
Pathologic Processes
Ischemia
Necrosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases