Retinal Microvascularization and Cardiovascular Disease

Terminated

• Conditions: Low Cardiovascular Risk Patients; High Cardiovascular Risk Patients
• Interventions: Other: Optical Coherence Tomography angiography; Other: Fundus; Other: cardiac ultrasound scan

• Registration Number: NCT03551717
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-14
• Study First Submitted: 2018-05-29
• Study First Submitted QC: 2018-06-08
• Study First Posted: 2018-06-11
• Primary Completion: 2019-04-19
• Study Completion: 2019-04-19
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-22
• Last Update Posted: 2020-05-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 155

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
High cardiovascular risk patients	Fundus	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)
High cardiovascular risk patients	Optical Coherence Tomography angiography	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)
High cardiovascular risk patients	cardiac ultrasound scan	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 patients	Fundus	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.
Low cardiovascular risk patients	Optical Coherence Tomography angiography	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.

Primary Outcome Measures

Name	Time	Method
Surface of the avascular zone in the central retina	Baseline

Trial Locations

Locations (1)

Chu Dijon Bourogne; 🇫🇷 Dijon, France