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

MR INFORM - a Randomized Non-inferiority Multicenter Trial Comparing MR Perfusion Imaging and Fractional Flow Reserve (FFR) to Guide Management of Patients With Stable Coronary Artery Disease

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Stable Angina; Myocardial Ischaemia
• Intervention / Treatment: Procedure: MR perfusion guidance; Procedure: FFR guidance

• Study Type: Interventional
• Enrollment (Actual): 915
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE1 7EH
    • King's College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurence of major adverse cardiac events (MACE)	Composite of all cause death, myocardial infarction and repeat revascularisation.	1year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: King's College London
• Collaborators: Bayer; Guy's and St Thomas' NHS Foundation Trust
• Investigators: Principal Investigator: Eike Nagel, MD, PhD, Goethe University Frankfurt

Publications and helpful links

General 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(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.

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: November 8, 2010
• First Submitted That Met QC Criteria: November 8, 2010
• First Posted (Estimate): November 9, 2010

Study Record Updates

• Last Update Posted (Actual): June 24, 2022
• Last Update Submitted That Met QC Criteria: June 21, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Cardiovascular Diseases; Adenosine; Magnetic Resonance Imaging; Pressure wire; Arteriosclerosis; Heart Diseases; FFR; Coronary Disease; Fractional Flow Reserve, Myocardial; MR perfusion
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Chest Pain; Angina Pectoris; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Ischemia; Angina, Stable
• Other Study ID Numbers: MR INFORM-10