MR INFORM - MR Perfusion Imaging to Guide Management of Patients With Stable Coronary Artery Disease
NCT ID: NCT01236807
Last Updated: 2022-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
915 participants
INTERVENTIONAL
2010-12-31
2016-12-31
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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MR Inform
Management guided by the result of the MR perfusion scan. Possible intervention: coronary artery revascularization.
MR perfusion guidance
Coronary revascularization guided by MR perfusion imaging
FFR Inform
Management guided by the result of FFR measurement. Possible intervention: coronary artery revascularization.
FFR guidance
Coronary revascularization guided by invasive angiography and FFR
Interventions
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MR perfusion guidance
Coronary revascularization guided by MR perfusion imaging
FFR guidance
Coronary revascularization guided by invasive angiography and FFR
Eligibility Criteria
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Inclusion Criteria
* ≥2 cardiovascular risk factors
* or positive exercise treadmill test
* Signed written informed consent
* age: at least 18 years
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Guy's and St Thomas' NHS Foundation Trust
OTHER
Bayer
INDUSTRY
King's College London
OTHER
Responsible Party
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Eike Nagel
Global Chief Investigator
Principal Investigators
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Eike Nagel, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Goethe University Frankfurt
Locations
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King's College
London, , United Kingdom
Countries
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References
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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(1):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. No abstract available.
Nagel E, Greenwood JP, McCann GP, Bettencourt N, Shah AM, Hussain ST, Perera D, Plein S, Bucciarelli-Ducci C, Paul M, Westwood MA, Marber M, Richter WS, Puntmann VO, Schwenke C, Schulz-Menger J, Das R, Wong J, Hausenloy DJ, Steen H, Berry C; MR-INFORM Investigators. Magnetic Resonance Perfusion or Fractional Flow Reserve in Coronary Disease. N Engl J Med. 2019 Jun 20;380(25):2418-2428. doi: 10.1056/NEJMoa1716734.
Other Identifiers
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MR INFORM-10
Identifier Type: -
Identifier Source: org_study_id
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