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

Acute Myocardial Infarction Clinical Trial

— iMODERN  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03298659
• Other study ID #: NL60107.029.16
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 21, 2017
• Est. completion date: February 23, 2027

Study information

• Verified date: November 2023
• Source: Radboud University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1146
• Est. completion date: February 23, 2027
• Est. primary completion date: February 23, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Coronary Artery Disease
• Infarction
• Multi Vessel Coronary Artery Disease
• Myocardial Infarction

Intervention

Diagnostic Test:
• iFR
Treatment guided by instantaneous wave-free ratio
• CMR
Treatment guided by stress perfusion CMR

Locations

Country	Name	City	State
Netherlands	Radboudumc	Nijmegen

Sponsors (5)

Lead Sponsor	Collaborator
Radboud University Medical Center	Biotronik AG, Duke Cardiovascular Magnetic Resonance Center, Stichting Life Sciences & Health, Volcano Europe BVBA/SPRL

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite end point of Major Adverse Cardiac Events	All-cause death, recurrent myocardial infarction and hospitalization for heart failure	3 years
Secondary	All cause mortality	All cause mortality at 6 and 12 months, 3 and 5 years	6 and 12 months, 3 and 5 years
Secondary	Cardiovascular mortality	Cardiovascular mortality at 6 and 12 months, 3 and 5 years	6 and 12 months, 3 and 5 years
Secondary	Myocardial infarction	Myocardial infarction at 6 and 12 months, 3 and 5 years	6 and 12 months, 3 and 5 years
Secondary	Cerebral events	Stroke and transient ischemic attack	6 and 12 months, 3 and 5 years
Secondary	Major bleeding	Haemorrhagic complications	6 months
Secondary	Unstable angina	Unstable angina including ECG-changes at 6 and 12 months, 3 and 5 years	6 and 12 months, 3 and 5 years
Secondary	Coronary angiography	Coronary angiography at 6 and 12 months, 3 and 5 years	6 and 12 months, 3 and 5 years
Secondary	Revascularization	Any revascularization at 6 and 12 months, 3 and 5 years	6 and 12 months, 3 and 5 years
Secondary	Target lesion failure	Failure and/or revascularization by percutaneous or surgical methods of the target lesion	6 and 12 months, 3 and 5 years
Secondary	Stent thrombosis	Stent thrombosis at 6 and 12 months, 3 and 5 years	6 and 12 months, 3 and 5 years
Secondary	Cost effectiveness analysis	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
Secondary	Quality of life	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