Clinical trial NCT03298659: iFR Guided Multi-vessel Revascularization During Percutaneous Coronary Intervention for Acute Myocardial Infarction
Official title: Instantaneous Wave-free Ratio Guided Multi-vessel revascularizatiOn During Percutaneous Coronary intervEntion for Acute myocaRdial iNfarction (iMODERN)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Acute Myocardial Infarction
Multi Vessel Coronary Artery Disease
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Volcano Europe BVBA/SPRL
name: Biotronik AG
name: Stichting Life Sciences & Health
name: Duke Cardiovascular Magnetic Resonance Center
First posted: 2017-10-02
Enrollment: 1146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 randomization to (A) an active treatment arm with complete, iFR-guided revascularization of every noninfarct coronary lesion \>50% and iFR ≤0.89; or (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.
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Composite end point of Major Adverse Cardiac Events
timeFrame: 3 years
Secondary outcomes:
measure: All cause mortality
timeFrame: 6 and 12 months, 3 and 5 years
measure: Cardiovascular mortality
timeFrame: 6 and 12 months, 3 and 5 years
measure: Myocardial infarction
timeFrame: 6 and 12 months, 3 and 5 years
measure: Cerebral events
timeFrame: 6 and 12 months, 3 and 5 years
measure: Major bleeding
timeFrame: 6 months
measure: Unstable angina
timeFrame: 6 and 12 months, 3 and 5 years
measure: Coronary angiography
timeFrame: 6 and 12 months, 3 and 5 years
measure: Revascularization
timeFrame: 6 and 12 months, 3 and 5 years
measure: Target lesion failure
timeFrame: 6 and 12 months, 3 and 5 years
measure: Stent thrombosis
timeFrame: 6 and 12 months, 3 and 5 years
measure: Cost effectiveness analysis
timeFrame: 6 and 12 months, 3 and 5 years
measure: Quality of life
timeFrame: 6 and 12 months, 3 and 5 years
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
Study officials:
References:
citation: 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.
citation: 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.