Contribution Of Nuclear Magnetic Resonance Imaging In The Study Of Diabetic Cardiomyopathy

• Sponsor: Assistance Publique Hopitaux De Marseille (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01295385
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Arms: 2
• Duration (Months): 51.9
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

Diagnosis of diabetic cardiomyopathy is then retained, supposing a change in the coronary microcirculation linked to an endothelial dysfunction. Abnormalities of the myocardial metabolism is frequently associated. It is regrettably about a hypothesis difficult to verify with current medical techniques.This deficiency being not only harmful to the diagnosis, but also to the assessment of the efficiency of the medical treatment on the myocardial metabolism and the endothelial function. Techniques of nuclear magnetic resonance offer interesting perspectives.

Condition or Disease	Intervention/Treatment	Phase
Diabetic; Cardiomyopathy	Other: NUCLEAR MAGNETIC RESONANCE IMAGING; Other: NUCLEAR MAGNETIC RESONANCE IMAGING	N/A

Detailed Description

These techniques allow in this context:

1. to quantify the myocardial blood flow at rest and after "cold pressor test" in a population of healthy volunteers. The myocardial blood flow will be obtained by estimating myocardial blood flow at the venous coronary sinus site. This allows us to quantify a possible endothelial dysfunction in a reproducible way. No MRI study in diabetic patients has ever been led until now with this technique.

2. to estimate the metabolic and structural abnormalities in this population, with particularly:

• Quantification of the myocardial metabolism in vivo by spectrometry of phosphorus

• Structural abnormalities: become integrated into the description of diabetic cardiomyopathy.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 25 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Contribution Of Nuclear Magnetic Resonance Imaging In The Study Of Diabetic Cardiomyopathy
• Study Start Date: Feb 1, 2011
• Anticipated Primary Completion Date: Jun 1, 2015
• Anticipated Study Completion Date: Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: healthy volunteers	Other: NUCLEAR MAGNETIC RESONANCE IMAGING; Techniques of nuclear magnetic resonance offer interesting perspectives in this context, and particularly to quantify the myocardial blood flow at rest and after "cold pressor test" in a population of healthy volunteers.
Active Comparator: patients with a diabetic cardiomyopathy	Other: NUCLEAR MAGNETIC RESONANCE IMAGING; Techniques of nuclear magnetic resonance offer interesting perspectives in this context, and particularly to quantify the myocardial blood flow will be obtained by estimating myocardial blood flow at the venous coronary sinus site. This allows us to quantify a possible endothelial dysfunction in a reproducible way. No MRI study in diabetic patients has ever been led until now with this technique and to estimate the metabolic and structural abnormalities in this population.

Outcome Measures

Primary Outcome Measures

1. To quantify the myocardial blood flow at rest and after "cold pressor test" in a population of healthy volunteers [12 months]

   The myocardial blood flow will be obtained by estimating myocardial blood flow at the venous coronary sinus site. This allows us to quantify a possible endothelial dysfunction in a reproducible way. No MRI study in diabetic patients has ever been led until now with this technique.

Secondary Outcome Measures

1. To estimate the metabolic and structural abnormalities in this population [12 months]

   Quantification of the myocardial metabolism in vivo by spectrometry of phosphorus 31 which allows to estimate the energy state of the heart by analyzing the phosphorous metabolites with high energy involved in the myocardial energetic metabolism. Structural abnormalities: evaluation of the fibrosis and the collagenic deposits by T1 mapping and measurement of relaxation T2 as well as the study of the late enhancement of gadolinium. These structural abnormalities become integrated into the description of diabetic cardiomyopathy.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• more than 18 years old

• patient type 2 diabetes affects taken care more than 5 years to Timone Hospital

• patient with a diabetic cardiomyopathy

• informed and consented

Exclusion Criteria:

• less than 18 years

• Pregnant woman

• patient type 1 diabetes affects

• patient presents a cardiomyopathy mixed (no diabetic)

• patients presents an arrhythmia ventriculaire or above - ventriculaire

• Unstable hémodynamique patients

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assistance Publique - Hopitaux de Marseille	Marseille		France	13

Sponsors and Collaborators

• Assistance Publique Hopitaux De Marseille

Investigators

• Principal Investigator: Jacques Quilici, Doctor, APHM

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Assistance Publique Hopitaux De Marseille
• ClinicalTrials.gov Identifier: NCT01295385
• Other Study ID Numbers: 2010-A00233-36; 2009-41
• First Posted: Feb 14, 2011
• Last Update Posted: Apr 22, 2015
• Last Verified: Apr 1, 2015

• Keywords provided by Assistance Publique Hopitaux De Marseille: type 2 diabetes; Cardiovascular diseases; coronary syndrome have abnormalities of glucidic metabolism
• Additional relevant MeSH terms: Cardiomyopathies; Diabetic Cardiomyopathies

Study Results

No Results Posted as of Apr 22, 2015