- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03551717
Retinal Microvascularization and Cardiovascular Disease (NESTOR)
Retinal Microvascularization and Cardiovascular Diseases
The main objective of this study is to investigate whether there are links between the blood vessels of the retina as a whole and heart and/or vascular diseases (cardiovascular diseases).
The arteries and veins of the retina are, like the large vessels of the human body (aorta, coronary, cerebral arteries), exposed to the complications of hypertension, diabetes, obesity, dyslipidemia (abnormal blood lipid profile) or tobacco. Several studies have shown that changes in retinal vessels (microvascularization) generally occur several years before damage to large peripheral vessels (macrovascularization). The study of the vessels of the retina is now possible thanks to simple and non-invasive examinations of photographs (not creating any lesion). They allow a painless evaluation of the vessels in the retina.
Ultimately, if this study is conclusive, the patient's cardiovascular risk could be evaluated simply by analysis of the vessels of the retina.
The study is being conducted in the ophthalmology and cardiology departments of Dijon University Hospital. In total, the investigators wish to include approximately 510 patients who present cardiovascular risk factors (255 low risk patients recruited in the ophthalmology department and 255 high risk patients hospitalized in the cardiology department).
All patients participating in the study will be asked to visit the ophthalmology department for a complete examination of the retina.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Dijon, France, 21000
- Chu Dijon Bourogne
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Person who gave oral consent
- High cardiovascular risk group: Adult patients hospitalized in the Cardiology Department of the University Hospital of Dijon Burgundy for acute coronary syndrome, patients between D1 and D5 of acute coronary syndrome, who can be moved for an ophthalmology consultation where the retinal imaging is done (heart monitoring in the presence of an experienced cardiologist if necessary)
- Low cardiovascular risk group: Adult patients over 40 years of age recruited in the Ophthalmology Department of the University Hospital of Dijon Burgundy following a standard consultation for cataract surgery, ocular surface pathologies and optical correction.
Exclusion Criteria:
- Person not affiliated to national health insurance
- Patient refusal
- Minor patient
- Protected patient
- Ophthalmological history (macular vascular or degenerative disorders)
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
High cardiovascular risk patients
Adult patients hospitalized in the Cardiology Department of the University Hospital of Dijon Burgundy for acute coronary syndrome, patients between D1 and D5 of acute coronary syndrome, who can be moved for an ophthalmology consultation where the retinal imaging is done (heart monitoring in the presence of an experienced cardiologist if necessary)
|
At the inclusion visit for all patients and at M3 only for 50 patients.
At the inclusion visit for all patients and at M3 only for 50 patients.
Only for 50 patients, 3 months after the initial cardiovascular event
|
|
Low cardiovascular risk patients
Adult patients recruited in the Ophthalmology Department of the University Hospital of Dijon Burgundy following a standard consultation for cataract surgery. The age balance of the patients included in the two groups will be checked regularly. |
At the inclusion visit for all patients and at M3 only for 50 patients.
At the inclusion visit for all patients and at M3 only for 50 patients.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Surface of the avascular zone in the central retina
Time Frame: Baseline
|
Baseline
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MEILLON AOI 2017
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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