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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
Sponsor:
Collaborators:
Guy's and St Thomas' NHS Foundation Trust
Bayer
Information provided by (Responsible Party):
Eike Nagel, King's College London

Tracking Information
First Submitted Date  ICMJE November 8, 2010
First Posted Date  ICMJE November 9, 2010
Last Update Posted Date December 28, 2016
Study Start Date  ICMJE December 2010
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2010)
Occurence of major adverse cardiac events (MACE) [ Time Frame: 1year ]
Composite of all cause death, myocardial infarction and repeat revascularisation.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01236807 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 8, 2010)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MR INFORM - MR Perfusion Imaging to Guide Management of Patients With Stable Coronary Artery Disease
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Coronary Artery Disease
  • Stable Angina
  • Myocardial Ischaemia
Intervention  ICMJE
  • Procedure: MR perfusion guidance
    Coronary revascularization guided by MR perfusion imaging
  • Procedure: FFR guidance
    Coronary revascularization guided by invasive angiography and FFR
Study Arms  ICMJE
  • Active Comparator: MR Inform
    Management guided by the result of the MR perfusion scan. Possible intervention: coronary artery revascularization.
    Intervention: Procedure: MR perfusion guidance
  • Active Comparator: FFR Inform
    Management guided by the result of FFR measurement. Possible intervention: coronary artery revascularization.
    Intervention: Procedure: FFR guidance
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 26, 2016)
915
Original Estimated Enrollment  ICMJE
 (submitted: November 8, 2010)
918
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01236807
Other Study ID Numbers  ICMJE MR INFORM-10
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eike Nagel, King's College London
Study Sponsor  ICMJE King's College London
Collaborators  ICMJE
  • Guy's and St Thomas' NHS Foundation Trust
  • Bayer
Investigators  ICMJE
Principal Investigator: Eike Nagel, MD, PhD Cooperative Weichteilsarkom Study Group
PRS Account King's College London
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP