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Completed

NCT Number: NCT01236807

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

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.

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Key information

Conditions

Coronary Artery Disease Angina Pectoris Angina, Stable Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Chest Pain Coronary Disease Heart Diseases Myocardial Ischaemia Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stable Angina Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King's College

London, SE1 7EH, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MR perfusion guidance

Procedure

Coronary revascularization guided by MR perfusion imaging

FFR guidance

Procedure

Coronary revascularization guided by invasive angiography and FFR

Primary outcomes

  1. Occurence of major adverse cardiac events (MACE)

    Time frame: 1year

    Composite of all cause death, myocardial infarction and repeat revascularisation.

Secondary outcomes

  1. Individual MACE

    Time frame: 1 year

    individual components as defined above

  2. Other adverse events

    Time frame: 1 year

    need for revascularization after initial treatment within 1 year

  3. Course of symptoms (angina, breathlessness)

    Time frame: 1 year

    CCS class, NYHA class

  4. Cost comparison

    Time frame: 1 year

    Costs related to MR- and FFR-guided selection for revascularisation

  5. changes in LV volumes and function

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

King's College London

Other

Collaborators

  • Bayer
  • Guy's and St Thomas' NHS Foundation Trust

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Nov 9, 2010
Registry last updated
Jun 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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