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

NCT01236807 | Completed DMC

• 1 other identifier: MR INFORM-10
• Study Type: interventional
• Target: 915
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Stable Angina; Myocardial Ischaemia

Keywords

Adenosine; Magnetic Resonance Imaging; MR perfusion; Fractional Flow Reserve, Myocardial; FFR; Pressure wire; Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis

Outcome Measures

Primary Outcomes (1)

• Occurence of major adverse cardiac events (MACE)

  Composite of all cause death, myocardial infarction and repeat revascularisation.

  1year

Secondary Outcomes (5)

• Individual MACE

  1 year

• Other adverse events

  1 year

• Course of symptoms (angina, breathlessness)

  1 year

• Cost comparison

  1 year

• changes in LV volumes and function

  1 year

Study Arms (2)

MR Inform

ACTIVE COMPARATOR

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

Procedure: MR perfusion guidance

FFR Inform

ACTIVE COMPARATOR

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

Procedure: FFR guidance

Interventions

MR perfusion guidance PROCEDURE

Coronary revascularization guided by MR perfusion imaging

MR Inform

FFR guidance PROCEDURE

Coronary revascularization guided by invasive angiography and FFR

FFR Inform

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• King's College London: lead
• Guy's and St Thomas' NHS Foundation Trust: collaborator
• Bayer: collaborator

Study Sites (1)

King's College

London, SE1 7EH, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 22992411 BACKGROUND

• 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.

  PMID: 31801003 BACKGROUND

• 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.

  PMID: 31216398 RESULT

MeSH Terms

Conditions

Coronary Artery Disease; Angina, Stable; Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Arterial Occlusive Diseases; Vascular Diseases; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eike Nagel, MD, PhD

  Goethe University Frankfurt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Global Chief Investigator

Study Record Dates

• First Submitted: November 8, 2010
• First Posted: November 9, 2010
• Study Start: December 1, 2010
• Primary Completion: August 1, 2016
• Study Completion: December 1, 2016
• Last Updated: June 24, 2022

Record last verified: 2022-06

Locations

GB (1)