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

Primary Purpose

Coronary Artery Disease, Stable Angina, Myocardial Ischaemia

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

MR perfusion guidance

FFR guidance

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Adenosine, Magnetic Resonance Imaging, MR perfusion, Fractional Flow Reserve, Myocardial, FFR, Pressure wire, Coronary Disease, Heart Diseases, Cardiovascular Diseases, Arteriosclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

King's College

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

MR Inform

FFR Inform

Arm Description

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

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

Outcomes

Primary Outcome Measures

Occurence of major adverse cardiac events (MACE)

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

Secondary Outcome Measures

Individual MACE

individual components as defined above

Other adverse events

need for revascularization after initial treatment within 1 year

Course of symptoms (angina, breathlessness)

CCS class, NYHA class

Cost comparison

Costs related to MR- and FFR-guided selection for revascularisation

changes in LV volumes and function

Full Information

NCT ID

NCT01236807

First Posted

November 8, 2010

Last Updated

June 21, 2022

Sponsor

King's College London

Collaborators

Guy's and St Thomas' NHS Foundation Trust, Bayer

1. Study Identification

Unique Protocol Identification Number

NCT01236807

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Completed

Study Start Date

December 2010 (undefined)

Primary Completion Date

August 2016 (Actual)

Study Completion Date

December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

King's College London

Collaborators

Guy's and St Thomas' NHS Foundation Trust, Bayer

4. Oversight

Data Monitoring Committee

Yes

5. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

915 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MR Inform

Arm Type

Active Comparator

Arm Description

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

Arm Title

FFR Inform

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

MR perfusion guidance

Intervention Description

Coronary revascularization guided by MR perfusion imaging

Intervention Type

Procedure

Intervention Name(s)

FFR guidance

Intervention Description

Coronary revascularization guided by invasive angiography and FFR

Primary Outcome Measure Information:

Title

Occurence of major adverse cardiac events (MACE)

Description

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

Time Frame

1year

Secondary Outcome Measure Information:

Title

Individual MACE

Description

individual components as defined above

Time Frame

1 year

Title

Other adverse events

Description

need for revascularization after initial treatment within 1 year

Time Frame

1 year

Title

Course of symptoms (angina, breathlessness)

Description

CCS class, NYHA class

Time Frame

1 year

Title

Cost comparison

Description

Costs related to MR- and FFR-guided selection for revascularisation

Time Frame

1 year

Title

changes in LV volumes and function

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eike Nagel, MD, PhD

Organizational Affiliation

Goethe University Frankfurt

Official's Role

Principal Investigator

Facility Information:

Facility Name

King's College

City

London

ZIP/Postal Code

SE1 7EH

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

22992411

Citation

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.

Results Reference

background

PubMed Identifier

31801003

Citation

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.

Results Reference

background

PubMed Identifier

31216398

Citation

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.

Results Reference

result

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

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