MR INFORM - MR Perfusion Imaging to Guide Management of Patients With Stable Coronary Artery Disease

Study Overview
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Brief Summary
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The purpose of this study is to determine if MR Perfusion Imaging is non-inferior to coronary angiography with measurement of Fractional Flow Reserve (FFR) in guiding management of patients with stable chest pain. All patients will undergo an MR Perfusion Imaging test. Further management will be guided by the result of the cardiac MRI in half of the patients (chosen by random). The other half will undergo coronary angiography with measurement of FFR. The result of this test alone will guide their further management. The result of the initial MR Perfusion test will not be available to the treating doctors of this group. All patients will receive optimal medical therapy (OMT) All patients will undergo follow-up to find out if they have any relevant heart related events.

Official Title
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MR INFORM - a Randomized Non-inferiority Multicenter Trial Comparing MR Perfusion Imaging and Fractional Flow Reserve (FFR) to Guide Management of Patients With Stable Coronary Artery Disease

Conditions
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Coronary Artery Disease, Stable Angina, Myocardial Ischaemia

Intervention / Treatment
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* Procedure: MR perfusion guidance
* Procedure: FFR guidance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Angina pectoris CCS class II and III and either ≥2 cardiovascular risk factors or positive exercise treadmill test Signed written informed consent age: at least 18 years Exclusion Criteria: contraindication to MR contraindication to adenosine infusion EF≤ 30% inability to lie supine for 60 minutes previous Coronary Artery Bypass Grafts revascularization within the previous 6 months cardiac arrhythmias (atrial fibrillation, >20 ectopic beats/min) poor renal function (eGFR <30ml/min) body weight > 140kg or waist perimeter > 95cm known allergy to contrast media

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MR Inform<br>Management guided by the result of the MR perfusion scan. Possible intervention: coronary artery revascularization. | Procedure: MR perfusion guidance<br>* Coronary revascularization guided by MR perfusion imaging<br>|
| Active Comparator: FFR Inform<br>Management guided by the result of FFR measurement. Possible intervention: coronary artery revascularization. | Procedure: FFR guidance<br>* Coronary revascularization guided by invasive angiography and FFR<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurence of major adverse cardiac events (MACE) | Composite of all cause death, myocardial infarction and repeat revascularisation. | 1year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Individual MACE | individual components as defined above | 1 year | 
| Other adverse events | need for revascularization after initial treatment within 1 year | 1 year | 
| Course of symptoms (angina, breathlessness) | CCS class, NYHA class | 1 year | 
| Cost comparison | Costs related to MR- and FFR-guided selection for revascularisation | 1 year | 
| changes in LV volumes and function |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adenosine, Magnetic Resonance Imaging, MR perfusion, Fractional Flow Reserve, Myocardial, FFR, Pressure wire, Coronary Disease, Heart Diseases, Cardiovascular Diseases, Arteriosclerosis