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

King's College London

Status: Completed

Conditions: Coronary Artery Disease; Stable Angina; Myocardial Ischaemia

Treatments: Procedure: MR perfusion guidance; Procedure: FFR guidance

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01236807

MR INFORM-10

Details and patient eligibility

About

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.

Enrollment: 915 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

915 participants in 2 patient groups

MR Inform

Active Comparator group

Description:

Management guided by the result of the MR perfusion scan. Possible intervention: coronary artery revascularization.

Treatment:

Procedure: MR perfusion guidance

FFR Inform

Active Comparator group

Description:

Management guided by the result of FFR measurement. Possible intervention: coronary artery revascularization.

Treatment:

Procedure: FFR guidance