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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2011 by King's College London
Sponsor:
Collaborators:
Guy's and St Thomas' NHS Foundation Trust
NIHR Comprehensive Biomedical Research Centre
Bayer
Information provided by:
King's College London
ClinicalTrials.gov Identifier:
NCT01236807
First received: November 8, 2010
Last updated: January 24, 2011
Last verified: January 2011
  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
Other: Cardiac MR perfusion scan
Other: Coronary angiography with FFR measurement

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 King's College London:

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


Secondary Outcome Measures:
  • Individual MACE [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    individual components as defined above

  • Other adverse events [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    need for revascularization after initial treatment within 1 year

  • Course of symptoms (angina, breathlessness) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    CCS class, NYHA class

  • Cost comparison [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Costs related to MR- and FFR-guided selection for revascularisation

  • changes in LV volumes and function [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 918
Study Start Date: December 2010
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (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.
Other: Cardiac MR perfusion scan
Need for revascularization guided by MR
Active Comparator: FFR Inform
Management guided by the result of FFR measurement.
Other: Coronary angiography with FFR measurement
Need for revascularization guided by FFR

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01236807

Contacts
Contact: Eike Nagel, Professor +44 20 7188 7242 eike.nagel@kcl.ac.uk

Locations
United Kingdom
King's College Recruiting
London, United Kingdom, SE1 7EH
Contact: Eike Nagel, Professor       eike.nagel@kcl.ac.uk   
Sponsors and Collaborators
King's College London
Guy's and St Thomas' NHS Foundation Trust
NIHR Comprehensive Biomedical Research Centre
Bayer
  More Information

No publications provided by King's College London

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof Eike Nagel, Chair of Cardiovascular Imaging, King's College London
ClinicalTrials.gov Identifier: NCT01236807     History of Changes
Other Study ID Numbers: MR INFORM-10
Study First Received: November 8, 2010
Last Updated: January 24, 2011
Health Authority: United Kingdom: Department of Health

Keywords provided by 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:
Angina, Stable
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Angina Pectoris
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Chest Pain
Heart Diseases
Pain
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on November 24, 2014