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NCT Number: NCT03298659

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Acute Myocardial Infarction Multi Vessel Coronary Artery Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radboudumc

Nijmegen, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

iFR

Diagnostic Test

Treatment guided by instantaneous wave-free ratio

cMR

Diagnostic Test

Treatment guided by stress perfusion CMR

Primary outcomes

  1. Composite end point of Major Adverse Cardiac Events

    Time frame: 3 years

    All-cause death, recurrent myocardial infarction and hospitalization for heart failure

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Biotronik AG
  • Duke Cardiovascular Magnetic Resonance Center
  • Stichting Life Sciences & Health
  • Volcano Europe BVBA/SPRL

Registry information

Official study title

Instantaneous Wave-free Ratio Guided Multi-vessel revascularizatiOn During Percutaneous Coronary intervEntion for Acute myocaRdial iNfarction (iMODERN)

Acronym: iMODERN

Important dates

Study start
2017
Primary completion
2025
Study completion
2027
First posted
Oct 2, 2017
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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