DiabeticNCT01295385
Contribution Of Nuclear Magnetic Resonance Imaging In The Study Of Diabetic Cardiomyopathy
A study testing NUCLEAR MAGNETIC RESONANCE IMAGING in people with Diabetic and Cardiomyopathy, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetic, Cardiomyopathy
- What is being tested?
- NUCLEAR MAGNETIC RESONANCE IMAGING
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2011to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Assistance Publique - Hopitaux de Marseille
Marseille, 13
Jacques Quilici, Doctor, +33491385973, jacques.quilici@ap-hm.fr
About this study
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.
Read the 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.
- Conditions
- Diabetic, Cardiomyopathy
- Being tested
- NUCLEAR MAGNETIC RESONANCE IMAGING
- Keywords
- type 2 diabetes, Cardiovascular diseases, coronary syndrome have abnormalities of glucidic metabolism
- Medical subject headings
- Cardiomyopathies, Diabetes Mellitus, Type 2, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NUCLEAR MAGNETIC RESONANCE IMAGINGOther
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 IMAGINGOther
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.
| Study group | Role | What they receive |
|---|---|---|
| healthy volunteers | Experimental | Not described Receives: Other: NUCLEAR MAGNETIC RESONANCE IMAGING |
| patients with a diabetic cardiomyopathy | Active comparator | Not described Receives: Other: NUCLEAR MAGNETIC RESONANCE IMAGING |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (1)
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionJun 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabeticStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacques Quilici, Doctor, Principal investigator, APHM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01295385
- Sponsor's protocol ID
- 2010-A00233-36
- Other IDs
- 2009-41
- Status last verified
- Apr 2015
- First submitted
- 26 Jan 2011
- Last updated
- 22 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution Of Nuclear Magnetic Resonance Imaging In The Study Of Diabetic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT01295385
- Acronym / sponsor ID
- 2010-A00233-36
- Conditions
- Diabetic, Cardiomyopathy
- Keywords
- type 2 diabetes, Cardiovascular diseases, coronary syndrome have abnormalities of glucidic metabolism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 14 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy volunteers | Experimental | Other: NUCLEAR MAGNETIC RESONANCE IMAGING |
| patients with a diabetic cardiomyopathy | Active comparator | Other: NUCLEAR MAGNETIC RESONANCE IMAGING |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NUCLEAR MAGNETIC RESONANCE IMAGINGTechniques 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. | Other | healthy volunteers |
| NUCLEAR MAGNETIC RESONANCE IMAGINGTechniques 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. | Other | patients with a diabetic cardiomyopathy |
Primary outcome
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.
1 secondary outcome
To estimate the metabolic and structural abnormalities in this population
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacques Quilici, Doctor principal investigator
APHM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NUCLEAR MAGNETIC RESONANCE IMAGING in people with Diabetic and Cardiomyopathy, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jacques Quilici, Doctor (+33491385973, jacques.quilici@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To quantify the myocardial blood flow at rest and after "cold pressor test" in a population of healthy volunteers (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2015.