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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01236807
First Posted: November 9, 2010
Last Update Posted: December 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Guy's and St Thomas' NHS Foundation Trust
Bayer
Information provided by (Responsible Party):
Eike Nagel, King's College London
  Purpose

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 Intervention
Coronary Artery Disease Stable Angina Myocardial Ischaemia Procedure: MR perfusion guidance Procedure: FFR guidance

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by Eike Nagel, King's College London:

Primary Outcome Measures:
  • Occurence of major adverse cardiac events (MACE) [ Time Frame: 1year ]
    Composite of all cause death, myocardial infarction and repeat revascularisation.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 915
Study Start Date: December 2010
Study Completion Date: December 2016
Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United Kingdom
King's College
London, United Kingdom, SE1 7EH
Sponsors and Collaborators
King's College London
Guy's and St Thomas' NHS Foundation Trust
Bayer
Investigators
Principal Investigator: Eike Nagel, MD, PhD Cooperative Weichteilsarkom Study Group
  More Information

Publications:
Responsible Party: Eike Nagel, Global Chief Investigator, King's College London
ClinicalTrials.gov Identifier: NCT01236807     History of Changes
Other Study ID Numbers: MR INFORM-10
First Submitted: November 8, 2010
First Posted: November 9, 2010
Last Update Posted: December 28, 2016
Last Verified: December 2016

Keywords provided by Eike Nagel, King's College London:
Adenosine
Magnetic Resonance Imaging
MR perfusion
Fractional Flow Reserve, Myocardial
FFR
Pressure wire
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Ischemia
Angina, Stable
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms