Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Magnetic Resonance Diabetic Cardiac Stress Imaging (MRDiabetics)

This study has been terminated.
(default of inclusion)
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00797082
First received: October 27, 2008
Last updated: July 29, 2012
Last verified: July 2012
  Purpose

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 Intervention Phase
Coronary Insufficiency
Device: MRI
Device: MPS
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Magnetic Resonance Diabetic Cardiac Stress Imaging : MRDIABETICS

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • positive diagnosis of coronary artery disease. [ Time Frame: 2 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • cost efficacy analysis for the diagnosis of coronary insufficiency in diabetic patients free of known coronary disease [ Time Frame: 26 months ] [ Designated as safety issue: No ]

Enrollment: 62
Study Start Date: November 2008
Study Completion Date: July 2012
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1

MRI = Myocardial Perfusion Stress and MPS = Myocardial Perfusion Scintigraphy

  • Diabetic patients
  • Coronary insufficiency
Device: MRI
MRI = Myocardial Perfusion Stress
Other Name: MRI
Device: MPS
MPS = Myocardial Perfusion Scintigraphy
Other Name: MPS

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00797082

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

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00797082     History of Changes
Other Study ID Numbers: P070149, AOR07022
Study First Received: October 27, 2008
Last Updated: July 29, 2012
Health Authority: France: Ministry of Health

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

ClinicalTrials.gov processed this record on November 24, 2014