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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01236807

Enrollment

915

Registered

2010-11-09

Start date

2010-12-31

Completion date

2016-12-31

Last updated

2022-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Myocardial Ischaemia, Stable Angina

Keywords

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

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.

Interventions

PROCEDUREMR perfusion guidance

Coronary revascularization guided by MR perfusion imaging

PROCEDUREFFR guidance

Coronary revascularization guided by invasive angiography and FFR

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026