High Cardiovascular Risk Patients Clinical Trial
— NESTOROfficial title:
Retinal Microvascularization and Cardiovascular Diseases
| Verified date | May 2020 |
| Source | Centre Hospitalier Universitaire Dijon |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Terminated |
| Enrollment | 155 |
| Est. completion date | April 19, 2019 |
| Est. primary completion date | April 19, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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) |
| Country | Name | City | State |
|---|---|---|---|
| France | Chu Dijon Bourogne | Dijon |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Universitaire Dijon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Surface of the avascular zone in the central retina | Baseline |