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

Radboud University Medical Center

Status: Active, not recruiting

Conditions: Multi Vessel Coronary Artery Disease; Acute Myocardial Infarction

Treatments: Diagnostic Test: CMR; Diagnostic Test: iFR

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03298659

NL60107.029.16

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,146 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,146 participants in 2 patient groups

Active iFR-guided revascularization

Experimental group

Description:

Decision to treat the nonculprit coronary stenosis if there is a significant pressure drop over the stenosis, as measured by intracoronary iFR assessment

Treatment:

Diagnostic Test: iFR

Deferred CMR-guided revascularization

Active Comparator group

Description:

Decision to treat the nonculprit coronary stenosis if perfusion defect visible in corresponding coronary territory as visualized on stress perfusion CMR imaging

Treatment:

Diagnostic Test: CMR