- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01295385
Contribution Of Nuclear Magnetic Resonance Imaging In The Study Of Diabetic Cardiomyopathy
April 20, 2015 updated by: Assistance Publique Hopitaux De Marseille
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
These techniques allow in this context:
- 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.
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 Type
Interventional
Enrollment (Anticipated)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jacques Quilici, Doctor
- Phone Number: +33491385973
- Email: jacques.quilici@ap-hm.fr
Study Locations
-
-
-
Marseille, France, 13
- Recruiting
- Assistance Publique - Hopitaux de Marseille
-
Contact:
- Jacques Quilici, Doctor
- Phone Number: +33491385973
- Email: jacques.quilici@ap-hm.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: healthy volunteers
|
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.
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.
|
Active Comparator: patients with a diabetic cardiomyopathy
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To quantify the myocardial blood flow at rest and after "cold pressor test" in a population of healthy volunteers
Time Frame: 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.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To estimate the metabolic and structural abnormalities in this population
Time Frame: 12 months
|
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jacques Quilici, Doctor, APHM
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2011
Primary Completion (Anticipated)
June 1, 2015
Study Completion (Anticipated)
June 1, 2015
Study Registration Dates
First Submitted
January 26, 2011
First Submitted That Met QC Criteria
February 11, 2011
First Posted (Estimate)
February 14, 2011
Study Record Updates
Last Update Posted (Estimate)
April 22, 2015
Last Update Submitted That Met QC Criteria
April 20, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2010-A00233-36
- 2009-41 (Other Identifier: CCRRC)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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