MR INFORM - MR Perfusion Imaging to Guide Management of Patients With Stable Coronary Artery Disease
Study Details
Study Description
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.
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All patients will undergo an MR Perfusion Imaging test.
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Further management will be guided by the result of the cardiac MRI in half of the patients (chosen by random).
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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.
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All patients will receive optimal medical therapy (OMT)
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All patients will undergo follow-up to find out if they have any relevant heart related events.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: MR Inform Management guided by the result of the MR perfusion scan. Possible intervention: coronary artery revascularization. |
Procedure: MR perfusion guidance
Coronary revascularization guided by MR perfusion imaging
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| Active Comparator: FFR Inform Management guided by the result of FFR measurement. Possible intervention: coronary artery revascularization. |
Procedure: FFR guidance
Coronary revascularization guided by invasive angiography and FFR
|
Outcome Measures
Primary Outcome Measures
- Occurence of major adverse cardiac events (MACE) [1year]
Composite of all cause death, myocardial infarction and repeat revascularisation.
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Angina pectoris CCS class II and III and either
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≥2 cardiovascular risk factors
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or positive exercise treadmill test
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Signed written informed consent
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age: at least 18 years
Exclusion Criteria:
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contraindication to MR
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contraindication to adenosine infusion
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EF≤ 30%
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inability to lie supine for 60 minutes
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previous Coronary Artery Bypass Grafts
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revascularization within the previous 6 months
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cardiac arrhythmias (atrial fibrillation, >20 ectopic beats/min)
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poor renal function (eGFR <30ml/min)
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body weight > 140kg or waist perimeter > 95cm
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known allergy to contrast media
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | King's College | London | United Kingdom | SE1 7EH |
Sponsors and Collaborators
- King's College London
- Guy's and St Thomas' NHS Foundation Trust
- Bayer
Investigators
- Principal Investigator: Eike Nagel, MD, PhD, Goethe University Frankfurt
Study Documents (Full-Text)
None provided.More Information
Publications
- Hussain ST, Paul M, Plein S, McCann GP, Shah AM, Marber MS, Chiribiri A, Morton G, Redwood S, MacCarthy P, Schuster A, Ishida M, Westwood MA, Perera D, Nagel E. Design and rationale of the MR-INFORM study: stress perfusion cardiovascular magnetic resonance imaging to guide the management of patients with stable coronary artery disease. J Cardiovasc Magn Reson. 2012 Sep 19;14:65. doi: 10.1186/1532-429X-14-65.
- Nagel E, Berry C. Magnetic Resonance Perfusion or Fractional Flow Reserve in Coronary Disease. Reply. N Engl J Med. 2019 Dec 5;381(23):2277-2278. doi: 10.1056/NEJMc1913968.
- MR INFORM-10