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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Assistance Publique Hopitaux De Marseille
Sponsor:
Information provided by:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT01295385
First received: January 26, 2011
Last updated: August 27, 2014
Last verified: August 2014
  Purpose

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 Intervention
Diabetic
Cardiomyopathy
Other: NUCLEAR MAGNETIC RESONANCE IMAGING

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Contribution Of Nuclear Magnetic Resonance Imaging In The Study Of Diabetic Cardiomyopathy

Resource links provided by NLM:


Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • To quantify the myocardial blood flow at rest and after "cold pressor test" in a population of healthy volunteers [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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:
  • To estimate the metabolic and structural abnormalities in this population [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    • 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.


Estimated Enrollment: 25
Study Start Date: September 2010
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
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: NCT01295385

Contacts
Contact: Jacques Quilici, Doctor +33491385973 jacques.quilici@ap-hm.fr

Locations
France
Assistance Publique - Hopitaux de Marseille Recruiting
Marseille, France, 13
Contact: Jacques Quilici, Doctor    +33491385973    jacques.quilici@ap-hm.fr   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Principal Investigator: Jacques Quilici, Doctor APHM
  More Information

No publications provided

Responsible Party: AP HM, Direction de la recherche
ClinicalTrials.gov Identifier: NCT01295385     History of Changes
Other Study ID Numbers: 2010-A00233-36, 2009-41
Study First Received: January 26, 2011
Last Updated: August 27, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 22, 2014