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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

915 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2016-12-31

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.

Detailed Description

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Conditions

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Coronary Artery Disease Stable Angina Myocardial Ischaemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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MR Inform

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

Group Type ACTIVE_COMPARATOR

MR perfusion guidance

Intervention Type PROCEDURE

Coronary revascularization guided by MR perfusion imaging

FFR Inform

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

Group Type ACTIVE_COMPARATOR

FFR guidance

Intervention Type PROCEDURE

Coronary revascularization guided by invasive angiography and FFR

Interventions

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MR perfusion guidance

Coronary revascularization guided by MR perfusion imaging

Intervention Type PROCEDURE

FFR guidance

Coronary revascularization guided by invasive angiography and FFR

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guy's and St Thomas' NHS Foundation Trust

OTHER

Sponsor Role collaborator

Bayer

INDUSTRY

Sponsor Role collaborator

King's College London

OTHER

Sponsor Role lead

Responsible Party

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Eike Nagel

Global Chief Investigator

Responsibility Role PRINCIPAL_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

Site Status

Countries

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United Kingdom

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.

Reference Type BACKGROUND
PMID: 22992411 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31801003 (View on PubMed)

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.

Reference Type RESULT
PMID: 31216398 (View on PubMed)

Other Identifiers

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MR INFORM-10

Identifier Type: -

Identifier Source: org_study_id

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