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

November 17, 2023 updated by: Radboud University Medical Center

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

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

Interventional

Enrollment (Actual)

1146

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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
6 and 12 months, 3 and 5 years
Cardiovascular mortality
Time Frame: 6 and 12 months, 3 and 5 years
Cardiovascular mortality at 6 and 12 months, 3 and 5 years
6 and 12 months, 3 and 5 years
Myocardial infarction
Time Frame: 6 and 12 months, 3 and 5 years
Myocardial infarction at 6 and 12 months, 3 and 5 years
6 and 12 months, 3 and 5 years
Cerebral events
Time Frame: 6 and 12 months, 3 and 5 years
Stroke and transient ischemic attack
6 and 12 months, 3 and 5 years
Major bleeding
Time Frame: 6 months
Haemorrhagic complications
6 months
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
6 and 12 months, 3 and 5 years
Coronary angiography
Time Frame: 6 and 12 months, 3 and 5 years
Coronary angiography at 6 and 12 months, 3 and 5 years
6 and 12 months, 3 and 5 years
Revascularization
Time Frame: 6 and 12 months, 3 and 5 years
Any revascularization at 6 and 12 months, 3 and 5 years
6 and 12 months, 3 and 5 years
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
6 and 12 months, 3 and 5 years
Stent thrombosis
Time Frame: 6 and 12 months, 3 and 5 years
Stent thrombosis at 6 and 12 months, 3 and 5 years
6 and 12 months, 3 and 5 years
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
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
6 and 12 months, 3 and 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 21, 2017

Primary Completion (Estimated)

February 23, 2025

Study Completion (Estimated)

February 23, 2027

Study Registration Dates

First Submitted

September 18, 2017

First Submitted That Met QC Criteria

September 26, 2017

First Posted (Actual)

October 2, 2017

Study Record Updates

Last Update Posted (Estimated)

November 20, 2023

Last Update Submitted That Met QC Criteria

November 17, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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