Clinical Trials Logo

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


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
See also
  Status Clinical Trial Phase
Recruiting NCT05371496 - Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction Phase 2
Completed NCT02892448 - Cardiac MRI for Metal on Metal Hip Resurfacing N/A
Active, not recruiting NCT02537782 - Myocardial Work and Metabolism in CRT N/A
Completed NCT02525185 - Contractile Reserve in Dyssynchrony: A Novel Principle to Identify Candidates for Cardiac Resynchronization Therapy
Terminated NCT01705509 - The Effects of Ranolazine on CPET Parameters in Ischemic Cardiomyopathy Patients (ERIC) N/A
Completed NCT00999947 - Arrhythmogenic Right Ventricular Dysplasia/Cardiomyopathy N/A
Completed NCT00626028 - Comparison of Inhaled Nitric Oxide and Oxygen in Participants Reactivity During Acute Pulmonary Vasodilator Testing Phase 3
Recruiting NCT00138931 - Genetics of Cardiovascular and Neuromuscular Disease
Withdrawn NCT02838355 - Employing End Tidal Capnography in Continuous Flow Ventricular Assist Device Patients N/A
Completed NCT01085955 - Investigation in Pregnancy Associate Cardiomyopathy N/A
Withdrawn NCT00428103 - Effects of Mitral Valve Repair With the Geoform Ring on Cardiomyopathy N/A
Recruiting NCT00273637 - Registry and Survey of Women With Pregnancy Related Cardiomyopathy N/A
Completed NCT00810550 - Carotid Ultrasound in the Evaluation of Heart Failure N/A
Completed NCT04603521 - Patients' Long-Term Survival of Obstructive Hypertrophic Cardiomyopathy (HCM)
Enrolling by invitation NCT03057561 - Efficacy of Dotarem® (Gd-DOTA) Versus Gadovist® (Gd-DO3A-butrol) for Late Gadolinium Enhancement Cardiac Magnetic Resonance N/A
Completed NCT00027170 - Technical Development of Cardiovascular Magnetic Resonance Imaging
Not yet recruiting NCT02917395 - Evaluate the Efficacy of Disopyramide Therapy in Hypertrophic Obstructive Cardiomyopathy Patients N/A
Completed NCT02331264 - Cardiac Assessment of Patients With Hip Implants N/A
Completed NCT02270840 - Budapest Upgrade CRT Study (Version 009-4.1) N/A
Completed NCT02164721 - Multicenter Automatic Defibrillator Implantation Trial - Chemotherapy-Induced Cardiomyopathy N/A