Myocardial IschemiaPEFDIANCT00685984
Peripheral Endothelial Function and Coronary Status in Asymptomatic Diabetic Patients
An observational study of Myocardial Ischemia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Silent myocardial ischemia is usual in type 2 diabetic patients and associated with coronary stenoses and endothelial dysfunction or both. We therefore hypothesized that peripheral endothelial dysfunction is a marker of silent myocardial ischemia. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Myocardial Ischemia
- How many people
- 173 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2008to Aug 2010
- Phase
- Observational
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * type 2 diabetes * overweight free of diabetes * control
Who may be able to join
- FOR TYPE 2 DIABETIC PATIENTS Asymptomatic:
- with normal resting ECG
- coronary primary prevention
- other cardiovascular risk factors justifying screening for silent myocardial ischemia and coronary stenoses in case of silent myocardial ischemia.
- FOR PATIENTS WITH OVERWEIGHT:
- Asymptomatic with normal resting ECG
Show all 14Show fewer
- coronary primary prevention
- Body mass index 25-40 kg/m²
- Without diabetes.
- CONTROLS Asymptomatic:
- coronary primary prevention
- Body mass index 18-25 kg/m²
- Without diabetes
- Without cardiovascular risk factors including dyslipidemia, hypertension, smoking habits, No treatment
Who cannot join
- pregnancy
- renal failure
- acrosyndrome
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Jean Verdier Service of Endocrinologie-Diabétologie-Nutrition
Bondy, 93140
About this study
Official title: Peripheral Endothelial Function and Coronary Status in Asymptomatic Type 2 Diabetic Patients: Relations With Coronary Microcirculation Assessed With Trans-thoracic Echo-doppler
Silent myocardial ischemia is usual in type 2 diabetic patients and associated with coronary stenoses and endothelial dysfunction or both. We therefore hypothesized that peripheral endothelial dysfunction is a marker of silent myocardial ischemia. The aim of the study is, in 120 asymptomatic type 2 diabetic patients, to evaluate the relations between coronary status, assessed with myocardial scintigraphy and subsequent coronary angiography in case of abnormality, and peripheral endothelial function, according to post-occlusive hyperaemia endothelium-dependent brachial artery dilation.
Read the detailed description
Coronary microcirculation, non invasively assessed with trans-thoracic echo-doppler (coronary blood flow before and after cold pressure testing), and biochemical markers of endothelial dysfunction will also be measured. Correlations between peripheral and coronary endothelial functions will be checked. The measurements will be performed and validated in two other groups
- 30 patients with overweight but free of diabetes, matched with the patients with diabetes for age, gender and body mass index
- 30 control subjects.Reproducibility of the methods will be assessed in 10 patients of the three groups of subjects.
- Conditions
- Myocardial Ischemia
- Keywords
- Type 2 diabetes, silent myocardial ischemia, endothelial function
- Medical subject headings
- Myocardial Ischemia, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described | |
| 2 | Not described | |
| 3 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-occlusive hyperaemia endothelium-dependent brachial artery dilation
Measured: immediate
Secondary outcomes (4)
noninvasive coronary microcirculation assessed with transthoracic ECHODOPPLER
Measured: immediate
cardiac autonomic neuropathy
Measured: immediate
cardiac transthoracic echography
Measured: immediate
biologic markers of endothelial function
Measured: immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2008 (estimated)
- Study startJan 2008
- Primary completionJun 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Myocardial IschemiaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Alfediam
- Responsible party
- Sponsor
- Investigators
- Emmanuel COSSON, MD phD, Principal investigator, Hôpital Jean Verdier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00685984
- Sponsor's protocol ID
- P070403
- Acronym
- PEFDIA
- Status last verified
- May 2011
- First submitted
- 26 May 2008
- Last updated
- 28 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cosson E, Pham I, Valensi P, Paries J, Attali JR, Nitenberg A. Impaired coronary endothelium-dependent vasodilation is associated with microalbuminuria in patients with type 2 diabetes and angiographically normal coronary arteries. Diabetes Care. 2006 Jan;29(1):107-12. doi: 10.2337/diacare.29.1.107.
PubMed 16373905Pham I, Nguyen MT, Valensi P, Rousseau H, Nitenberg A, Vicaut E, Cosson E. Noninvasive study of coronary microcirculation response to a cold pressor test. Eur J Clin Invest. 2015 Feb;45(2):135-43. doi: 10.1111/eci.12389. Epub 2015 Jan 7.
PubMed 25490913Nguyen MT, Pham I, Valensi P, Rousseau H, Vicaut E, Laguillier-Morizot C, Nitenberg A, Cosson E. Flow-mediated-paradoxical vasoconstriction is independently associated with asymptomatic myocardial ischemia and coronary artery disease in type 2 diabetic patients. Cardiovasc Diabetol. 2014 Jan 15;13:20. doi: 10.1186/1475-2840-13-20.
PubMed 24428877
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Endothelial Function and Coronary Status in Asymptomatic Type 2 Diabetic Patients: Relations With Coronary Microcirculation Assessed With Trans-thoracic Echo-doppler
- ClinicalTrials.gov ID
- NCT00685984
- Acronym / sponsor ID
- PEFDIA / P070403
- Conditions
- Myocardial Ischemia
- Keywords
- Type 2 diabetes, silent myocardial ischemia, endothelial function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Alfediam
- Study start
- Jan 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 29 May 2008 (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.
Silent myocardial ischemia is usual in type 2 diabetic patients and associated with coronary stenoses and endothelial dysfunction or both. We therefore hypothesized that peripheral endothelial dysfunction is a marker of silent myocardial ischemia. The aim of the study is, in 120 asymptomatic type 2 diabetic patients, to evaluate the relations between coronary status, assessed with myocardial scintigraphy and subsequent coronary angiography in case of abnormality, and peripheral endothelial function, according to post-occlusive hyperaemia endothelium-dependent brachial artery dilation.
Detailed description
Coronary microcirculation, non invasively assessed with trans-thoracic echo-doppler (coronary blood flow before and after cold pressure testing), and biochemical markers of endothelial dysfunction will also be measured. Correlations between peripheral and coronary endothelial functions will be checked. The measurements will be performed and validated in two other groups
- 30 patients with overweight but free of diabetes, matched with the patients with diabetes for age, gender and body mass index
- 30 control subjects.Reproducibility of the methods will be assessed in 10 patients of the three groups of subjects.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | – |
| 2 | – | – |
| 3 | – | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * type 2 diabetes * overweight free of diabetes * control
Key inclusion criteria (14 listed)
- with normal resting ECG
- coronary primary prevention
- other cardiovascular risk factors justifying screening for silent myocardial ischemia and coronary stenoses in case of silent myocardial ischemia.
- Asymptomatic with normal resting ECG
- coronary primary prevention
Key exclusion criteria (3 listed)
- pregnancy
- renal failure
- acrosyndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Post-occlusive hyperaemia endothelium-dependent brachial artery dilation
Time frame: immediate
4 secondary outcomes
noninvasive coronary microcirculation assessed with transthoracic ECHODOPPLER
Time frame: immediate
cardiac autonomic neuropathy
Time frame: immediate
cardiac transthoracic echography
Time frame: immediate
biologic markers of endothelial function
Time frame: immediate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2011.
- Results publication: PubMed 16373905Cosson E, Pham I, Valensi P, Paries J, Attali JR, Nitenberg A. Impaired coronary endothelium-dependent vasodilation is associated with microalbuminuria in patients with type 2 diabetes and angiographically normal coronary arteries. Diabetes Care. 2006 Jan;29(1):107-12. doi: 10.2337/diacare.29.1.107.
- Derived from this study: PubMed 25490913Pham I, Nguyen MT, Valensi P, Rousseau H, Nitenberg A, Vicaut E, Cosson E. Noninvasive study of coronary microcirculation response to a cold pressor test. Eur J Clin Invest. 2015 Feb;45(2):135-43. doi: 10.1111/eci.12389. Epub 2015 Jan 7.
- Derived from this study: PubMed 24428877Nguyen MT, Pham I, Valensi P, Rousseau H, Vicaut E, Laguillier-Morizot C, Nitenberg A, Cosson E. Flow-mediated-paradoxical vasoconstriction is independently associated with asymptomatic myocardial ischemia and coronary artery disease in type 2 diabetic patients. Cardiovasc Diabetol. 2014 Jan 15;13:20. doi: 10.1186/1475-2840-13-20.
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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.
Emmanuel COSSON, MD phD principal investigator
Hôpital Jean Verdier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Ischemia, run by Assistance Publique - Hôpitaux de Paris 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 14 inclusion and 3 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: finished, as of the sponsor's last update on 28 Oct 2011. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-occlusive hyperaemia endothelium-dependent brachial artery dilation (time frame: immediate). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00685984, which also lists 3 linked publications.
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 28 Oct 2011.