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

Cardiomyopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01295385
• Other study ID #: 2010-A00233-36
• Secondary ID: 2009-41
• Status: Recruiting
• Phase: N/A
• First received: January 26, 2011
• Last updated: April 20, 2015
• Start date: February 2011
• Est. completion date: June 2015

Study information

• Verified date: April 2015
• Source: Assistance Publique Hopitaux De Marseille
• Contact: Jacques Quilici, Doctor
• Phone: +33491385973
• Email: jacques.quilici[@]ap-hm.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy
• Diabetic
• Diabetic Cardiomyopathies

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	Assistance Publique - Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months	No
Secondary	To estimate the metabolic and structural abnormalities in this population	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.	12 months	No