Magnetic Resonance Diabetic Cardiac Stress Imaging (MRDiabetics)

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. Identifier: NCT00797082
Recruitment Status : Terminated (default of inclusion)
First Posted : November 25, 2008
Last Update Posted : July 31, 2012
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
The aim of the study is to assess the efficacy of cardiac MRI to detect coronary disease in diabetic patients. Cardiac MRI will be compared to myocardial scintigraphy with is the method being used in current practice. The investigators believe that cardiac MRI will be as efficient if not better that myocardial scintigraphy to detect tight coronary artery stenosis with the advantage of providing no radiation to the patient. Moreover, the investigators believe that cardiac MR will add additional information regarding possible undetected myocardial infarction.

Condition or disease Intervention/treatment Phase
Coronary Insufficiency Device: MRI Device: MPS Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Magnetic Resonance Diabetic Cardiac Stress Imaging : MRDIABETICS
Study Start Date : November 2008
Actual Primary Completion Date : March 2011
Actual Study Completion Date : July 2012

Arm Intervention/treatment
Experimental: 1

MRI = Myocardial Perfusion Stress and MPS = Myocardial Perfusion Scintigraphy

  • Diabetic patients
  • Coronary insufficiency
Device: MRI
MRI = Myocardial Perfusion Stress

Device: MPS
MPS = Myocardial Perfusion Scintigraphy

Primary Outcome Measures :
  1. positive diagnosis of coronary artery disease. [ Time Frame: 2 days ]

Secondary Outcome Measures :
  1. cost efficacy analysis for the diagnosis of coronary insufficiency in diabetic patients free of known coronary disease [ Time Frame: 26 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Patient older than 18 years old
  • Patient with health care coverage ( social security or universal health coverage - CMU)
  • Patient who had a prior medical examination
  • Diabetic patient (type 1 or type 2) with no known coronary artery disease, addressed for myocardial scintigraphy
  • Patient who was informed of objectives and constraints of the study and having given his consent in writing


  • Pregnant and lactating women
  • Patients with known coronary disease (myocardial infarction, unstable angina, history of coronary artery disease)
  • Patient with contra-indication for MRI claustrophobia, metallic foreign body in the eye, pacemakers, mechanical heart valve laid before 1985 Patient with specific contra-indication to vasodilators
  • Severe hypotension < 90 mmHg
  • Hypersensitivity to adenosine or dipyridamole
  • Bronchial asthma, chronic obstructive pulmonary disease with obvious bronchospasm. Severe and known pulmonary artery hypertension
  • Atrioventricular 2nd or 3rd degree blocks, long QT syndrome
  • Tight known carotid artery stenosis (70% NASCET criterion), with no possible vascular substitution
  • Patient with contra-indication to cardiac stimulation
  • Unstable hemodynamic state and / or unstable angina not stabilized by drug treatment and/or decompensated or severe heart failure
  • Known comorbidities : pregnancy and lactation, tight aortic valve or mitral valve stenosis, severe left-right shunt, severe pericarditis or abundant pericardial effusion
  • Contra-indication to coronary angiography
  • Renal failure with creatinine clearance < 30 ml / min
  • Hypersensitivity to contrast agents that resulted in a serious complication

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 identifier (NCT number): NCT00797082

Hopital Bichat
Paris, France, 75018
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Principal Investigator: Jean Michel SERFATY, PHU ASSISTANCE PUBLIQUE

Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT00797082     History of Changes
Other Study ID Numbers: P070149
AOR07022 ( Other Identifier: French Ministry )
First Posted: November 25, 2008    Key Record Dates
Last Update Posted: July 31, 2012
Last Verified: July 2012

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Coronary disease
Magnetic resonance imaging
Myocardial Perfusion Scintigraphy
Coronary angiography