Contribution Of Nuclear Magnetic Resonance Imaging In The Study Of Diabetic Cardiomyopathy
Primary Purpose
Diabetic, Cardiomyopathy
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
NUCLEAR MAGNETIC RESONANCE IMAGING
NUCLEAR MAGNETIC RESONANCE IMAGING
Sponsored by
About this trial
This is an interventional diagnostic trial for Diabetic focused on measuring type 2 diabetes, Cardiovascular diseases, coronary syndrome have abnormalities of glucidic metabolism
Eligibility 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
Sites / Locations
- Assistance Publique - Hopitaux de MarseilleRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
healthy volunteers
patients with a diabetic cardiomyopathy
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01295385
First Posted
January 26, 2011
Last Updated
April 20, 2015
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT01295385
Brief Title
Contribution Of Nuclear Magnetic Resonance Imaging In The Study Of Diabetic Cardiomyopathy
Official Title
Contribution Of Nuclear Magnetic Resonance Imaging In The Study Of Diabetic Cardiomyopathy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2011 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
June 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic, Cardiomyopathy
Keywords
type 2 diabetes, Cardiovascular diseases, coronary syndrome have abnormalities of glucidic metabolism
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
healthy volunteers
Arm Type
Experimental
Arm Title
patients with a diabetic cardiomyopathy
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
NUCLEAR MAGNETIC RESONANCE IMAGING
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
NUCLEAR MAGNETIC RESONANCE IMAGING
Intervention Description
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.
Primary Outcome Measure Information:
Title
To quantify the myocardial blood flow at rest and after "cold pressor test" in a population of healthy volunteers
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
To estimate the metabolic and structural abnormalities in this population
Description
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jacques Quilici, Doctor
Phone
+33491385973
Email
jacques.quilici@ap-hm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacques Quilici, Doctor
Organizational Affiliation
APHM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique - Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacques Quilici, Doctor
Phone
+33491385973
Email
jacques.quilici@ap-hm.fr
12. IPD Sharing Statement
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Contribution Of Nuclear Magnetic Resonance Imaging In The Study Of Diabetic Cardiomyopathy
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