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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01236807
• Other study ID #: MR INFORM-10
• Status: Completed
• Phase: N/A
• Start date: December 2010
• Est. completion date: December 2016

Study information

• Verified date: June 2022
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 915
• Est. completion date: December 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Angina, Stable
• Coronary Artery Disease
• Coronary Disease
• Ischemia
• Myocardial Ischaemia
• Myocardial Ischemia
• Stable Angina

Intervention

Procedure:
• MR perfusion guidance
Coronary revascularization guided by MR perfusion imaging
• FFR guidance
Coronary revascularization guided by invasive angiography and FFR

Locations

Country	Name	City	State
United Kingdom	King's College	London

Sponsors (3)

Lead Sponsor	Collaborator
King's College London	Bayer, Guy's and St Thomas' NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & 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;14:65. doi: 10.1186/1532-429X-14-65. — View 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. — View 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 Inv — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurence of major adverse cardiac events (MACE)	Composite of all cause death, myocardial infarction and repeat revascularisation.	1year
Secondary	Individual MACE	individual components as defined above	1 year
Secondary	Other adverse events	need for revascularization after initial treatment within 1 year	1 year
Secondary	Course of symptoms (angina, breathlessness)	CCS class, NYHA class	1 year
Secondary	Cost comparison	Costs related to MR- and FFR-guided selection for revascularisation	1 year
Secondary	changes in LV volumes and function		1 year