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

Not Applicable

Completed

• Conditions: Myocardial Ischaemia; Coronary Artery Disease; Stable Angina
• Interventions: Procedure: FFR guidance; Procedure: MR perfusion guidance

• Registration Number: NCT01236807
• Lead Sponsor: King's College London

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-11-08
• Study First Submitted QC: 2010-11-08
• Study First Posted: 2010-11-09
• Study Start: 2010-12
• Primary Completion: 2016-08
• Study Completion: 2016-12
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-21
• Last Update Posted: 2022-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 915

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FFR Inform	FFR guidance	Management guided by the result of FFR measurement. Possible intervention: coronary artery revascularization.
MR Inform	MR perfusion guidance	Management guided by the result of the MR perfusion scan. Possible intervention: coronary artery revascularization.

Primary Outcome Measures

Name	Time	Method
Occurence of major adverse cardiac events (MACE)	1year	Composite of all cause death, myocardial infarction and repeat revascularisation.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

King's College; 🇬🇧 London, United Kingdom