Magnetic Resonance Diabetic Cardiac Stress Imaging

NCT00797082 | Terminated Phase 4

• 2 other identifiers: P070149AOR07022
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Insufficiency

Keywords

Diabetic; Coronary disease; Atherosclerosis; Magnetic resonance imaging; Myocardial Perfusion Scintigraphy; Coronary angiography

Outcome Measures

Primary Outcomes (1)

• positive diagnosis of coronary artery disease.

  2 days

Secondary Outcomes (1)

• cost efficacy analysis for the diagnosis of coronary insufficiency in diabetic patients free of known coronary disease

  26 months

Study Arms (1)

1

EXPERIMENTAL

MRI = Myocardial Perfusion Stress and MPS = Myocardial Perfusion Scintigraphy * Diabetic patients * Coronary insufficiency

Device: MRI; Device: MPS

Interventions

MRI DEVICE

MRI = Myocardial Perfusion Stress

1

MPS DEVICE

MPS = Myocardial Perfusion Scintigraphy

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hopital Bichat

Paris, 75018, France

Location

MeSH Terms

Conditions

Coronary Disease; Atherosclerosis

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Jean Michel SERFATY, PHU

  ASSISTANCE PUBLIQUE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2008
• First Posted: November 25, 2008
• Study Start: November 1, 2008
• Primary Completion: March 1, 2011
• Study Completion: July 1, 2012
• Last Updated: July 31, 2012

Record last verified: 2012-07

Locations

FR (1)