Clinical trial NCT01236807: 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
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: Guy's and St Thomas' NHS Foundation Trust
name: Bayer
First posted: 2010-11-09
Enrollment: 915
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Occurence of major adverse cardiac events (MACE)
timeFrame: 1year
Secondary outcomes:
measure: Individual MACE
timeFrame: 1 year
measure: Other adverse events
timeFrame: 1 year
measure: Course of symptoms (angina, breathlessness)
timeFrame: 1 year
measure: Cost comparison
timeFrame: 1 year
measure: changes in LV volumes and function
timeFrame: 1 year
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College
Study officials:
affiliation: Goethe University Frankfurt
name: Eike Nagel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.