MR INFORM - MR Perfusion Imaging to Guide Management of Patients With Stable Coronary Artery Disease
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|ClinicalTrials.gov Identifier: NCT01236807|
Recruitment Status : Completed
First Posted : November 9, 2010
Last Update Posted : December 28, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease Stable Angina Myocardial Ischaemia||Procedure: MR perfusion guidance Procedure: FFR guidance||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||915 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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 Start Date :||December 2010|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||December 2016|
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
- Occurence of major adverse cardiac events (MACE) [ Time Frame: 1year ]Composite of all cause death, myocardial infarction and repeat revascularisation.
- Individual MACE [ Time Frame: 1 year ]individual components as defined above
- Other adverse events [ Time Frame: 1 year ]need for revascularization after initial treatment within 1 year
- Course of symptoms (angina, breathlessness) [ Time Frame: 1 year ]CCS class, NYHA class
- Cost comparison [ Time Frame: 1 year ]Costs related to MR- and FFR-guided selection for revascularisation
- changes in LV volumes and function [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01236807
|London, United Kingdom, SE1 7EH|
|Principal Investigator:||Eike Nagel, MD, PhD||Goethe University Frankfurt|