Status:
TERMINATED
Magnetic Resonance Diabetic Cardiac Stress Imaging
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Coronary Insufficiency
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ...
Detailed Description
Rationale: The incidence of diabetes is rising constantly. According to the WHO projections, the population of diabetics will double by 2025. In France, the current population of diabetics is estimat...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- 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
- EXCLUSION CRITERIA:
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00797082
Start Date
November 1 2008
End Date
July 1 2012
Last Update
July 31 2012
Active Locations (1)
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1
Hopital Bichat
Paris, France, 75018