iFR Guided Multi-vessel Revascularization During Percutaneous Coronary Intervention for Acute Myocardial Infarction (iMODERN)
Instantaneous Wave-free Ratio Guided Multi-vessel revascularizatiOn During Percutaneous Coronary intervEntion for Acute myocaRdial iNfarction (iMODERN)
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 Overview
Status
Intervention / Treatment
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 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Nijmegen, Netherlands
- Radboudumc
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18 years and older
- 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 ST-elevation myocardial infarction or coronary artery bypass graft
- 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 noninfarct target lesions
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
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
|
Treatment guided by stress perfusion CMR
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Composite end point of Major Adverse Cardiac Events
Time Frame: 3 years
|
All-cause death, recurrent myocardial infarction and hospitalization for heart failure
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
6 and 12 months, 3 and 5 years
|
|
Composite end point of Major Adverse Cardiac Events
Time Frame: 6 months, 12 months, and 5 years
|
All-cause death, recurrent myocardial infarction and hospitalization for heart failure
|
6 months, 12 months, and 5 years
|
|
Cardiac death
Time Frame: 6 months, 12 months, 3 years, and 5 years
|
Death from cardiovascular causes
|
6 months, 12 months, 3 years, and 5 years
|
|
Myocardial infarction
Time Frame: 6 months, 12 months, 3 years, and 5 years
|
Myocardial infarction
|
6 months, 12 months, 3 years, and 5 years
|
|
Stroke
Time Frame: 6 months, 12 months, 3 years, and 5 years
|
Stroke
|
6 months, 12 months, 3 years, and 5 years
|
|
Transient ischemic attack
Time Frame: 6 months, 12 months, 3 years, and 5 years
|
TIA
|
6 months, 12 months, 3 years, and 5 years
|
|
Major bleeding
Time Frame: 6 months, 12 months, 3 years, and 5 years
|
Haemorrhagic complications
|
6 months, 12 months, 3 years, and 5 years
|
|
Unstable angina
Time Frame: 6 months, 12 months, 3 years, and 5 years
|
Unstable angina including ECG-changes
|
6 months, 12 months, 3 years, and 5 years
|
|
Revascularization
Time Frame: 6 months, 12 months, 3 years, and 5 years
|
Any coronary artery revascularization
|
6 months, 12 months, 3 years, and 5 years
|
|
Coronary angiography
Time Frame: 6 months, 12 months, 3 years, and 5 years
|
Coronary angiography
|
6 months, 12 months, 3 years, and 5 years
|
|
Stent thrombosis
Time Frame: 6 months, 12 months, 3 years, and 5 years
|
Stent thrombosis
|
6 months, 12 months, 3 years, and 5 years
|
|
Target lesion failure
Time Frame: 6 months, 12 months, 3 years, and 5 years
|
Failure and/or revascularization by percutaneous or surgical methods of the target lesion, including cardiac death, MI, or clinically-driven target lesion revascularization
|
6 months, 12 months, 3 years, and 5 years
|
|
Quality of life
Time Frame: From enrolment to 6 and 12 months, 3 and 5 years follow-up
|
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
|
From enrolment to 6 and 12 months, 3 and 5 years follow-up
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Ong P, Martinez Pereyra V, Sechtem U, Bekeredjian R. Management of patients with ST-segment myocardial infarction and multivessel disease: what are the options in 2022? Coron Artery Dis. 2022 Sep 1;33(6):485-489. doi: 10.1097/MCA.0000000000001157. Epub 2022 Jul 11.
- Beijnink CWH, Thim T, van der Heijden DJ, Klem I, Al-Lamee R, Vos JL, Koop Y, Dijkgraaf MGW, Beijk MAM, Kim RJ, Davies J, Raposo L, Baptista SB, Escaned J, Piek JJ, Maeng M, van Royen N, Nijveldt R. Instantaneous wave-free ratio guided multivessel revascularisation during percutaneous coronary intervention for acute myocardial infarction: study protocol of the randomised controlled iMODERN trial. BMJ Open. 2021 Jan 15;11(1):e044035. doi: 10.1136/bmjopen-2020-044035.
- Nijveldt R, Maeng M, Beijnink CWH, Piek JJ, Al-Lamee RK, Raposo L, Baptista SB, Escaned J, Davies J, Klem I, Yosofi B, van Geuns RM, Frederiksen CA, Jakobsen L, El Barzouhi A, van der Heijden DJ, Ilhan M, Rasoul S, Brinckman S, Saraber C, Jones DA, Petersen SE, Podlesnikar T, Bunc M, Beijk MAM, Piers LH, van Rees JB, Seligman H, Cole G, Iglesias JF, Degrauwe S, van 't Hof AWJ, Lipsic E, Pundziute-do Prado G, Chattranukulchai P, Rodriguez-Palomares JF, Rigger J, Meuwissen M, Kleijn L, Pereira B, Monti L, van der Schaaf RJ, Sanchis J, Belli G, Tijssen JGP, Thim T, van Royen N; iMODERN Investigators. Immediate or Deferred Nonculprit-Lesion PCI in Myocardial Infarction. N Engl J Med. 2026 Mar 5;394(10):958-968. doi: 10.1056/NEJMoa2512918. Epub 2025 Oct 28.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NL60107.029.16
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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