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

Not Applicable

• Conditions: Diabetic; Cardiomyopathy
• Interventions: Other: NUCLEAR MAGNETIC RESONANCE IMAGING

• Registration Number: NCT01295385
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

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.

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 31.

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

Study Timeline

• Study First Submitted: 2011-01-26
• Study Start: 2011-02
• Study First Submitted QC: 2011-02-11
• Study First Posted: 2011-02-14
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-20
• Last Update Posted: 2015-04-22
• Primary Completion: 2015-06
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
patients with a diabetic cardiomyopathy	NUCLEAR MAGNETIC RESONANCE IMAGING	-
healthy volunteers	NUCLEAR MAGNETIC RESONANCE IMAGING	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Assistance Publique - Hopitaux de Marseille; 🇫🇷 Marseille, France