An interventional study of iFR and CMR in Acute Myocardial Infarction and Multi Vessel Coronary Artery Disease, sponsored by Radboud University Medical Center. Active, not recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by Radboud University Medical Center · Not applicable, Interventional, and Diagnostic
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.
Exclusion Criteria:
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
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 instantaneous wave-free ratio
Treatment guided by stress perfusion CMR
Composite end point of Major Adverse Cardiac Events
All-cause death, recurrent myocardial infarction and hospitalization for heart failure
Time frame: 3 years
Composite end point of Major Adverse Cardiac Events
All-cause death, recurrent myocardial infarction and hospitalization for heart failure
Time frame: 6 months, 12 months, and 5 years
Cardiac death
Death from cardiovascular causes
Time frame: 6 months, 12 months, 3 years, and 5 years
Myocardial infarction
Myocardial infarction
Time frame: 6 months, 12 months, 3 years, and 5 years
Stroke
Stroke
Time frame: 6 months, 12 months, 3 years, and 5 years
Transient ischemic attack
TIA
Time frame: 6 months, 12 months, 3 years, and 5 years
Major bleeding
Haemorrhagic complications
Time frame: 6 months, 12 months, 3 years, and 5 years
Unstable angina
Unstable angina including ECG-changes
Time frame: 6 months, 12 months, 3 years, and 5 years
Revascularization
Any coronary artery revascularization
Time frame: 6 months, 12 months, 3 years, and 5 years
Coronary angiography
Coronary angiography
Time frame: 6 months, 12 months, 3 years, and 5 years
Stent thrombosis
Stent thrombosis
Time frame: 6 months, 12 months, 3 years, and 5 years
Target lesion failure
Failure and/or revascularization by percutaneous or surgical methods of the target lesion, including cardiac death, MI, or clinically-driven target lesion revascularization
Time frame: 6 months, 12 months, 3 years, and 5 years
Cost effectiveness analysis
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)
Time frame: 6 and 12 months, 3 and 5 years
Quality of life
Quality of life is measured by standardized questionnaires, i.e. SAQ, EQ-5D-5L and Minnesota heart failure questionnaire, at 6 and 12 months, 3 and 5 years
Time frame: From enrolment to 6 and 12 months, 3 and 5 years follow-up
Plan to share: No
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Radboud University Medical Center