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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2026
  • participants needed
    1146
  • sponsor
    Radboud University
Updated on 16 December 2021
stenosis
stemi
percutaneous coronary intervention

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.

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.

Details
Condition Acute Myocardial Infarction, Multi Vessel Coronary Artery Disease
Treatment iFR, CMR, CMR
Clinical Study IdentifierNCT03298659
SponsorRadboud University
Last Modified on16 December 2021

Eligibility

Yes No Not Sure

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
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