Retinal Microvascularization and Cardiovascular Disease

NCT ID: NCT03551717

Last Updated: 2020-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

155 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-14

Study Completion Date

2019-04-19

Brief Summary

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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

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Conditions

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High Cardiovascular Risk Patients Low Cardiovascular Risk Patients

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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)

Optical Coherence Tomography angiography

Intervention Type OTHER

At the inclusion visit for all patients and at M3 only for 50 patients.

Fundus

Intervention Type OTHER

At the inclusion visit for all patients and at M3 only for 50 patients.

cardiac ultrasound scan

Intervention Type OTHER

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.

Optical Coherence Tomography angiography

Intervention Type OTHER

At the inclusion visit for all patients and at M3 only for 50 patients.

Fundus

Intervention Type OTHER

At the inclusion visit for all patients and at M3 only for 50 patients.

Interventions

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Optical Coherence Tomography angiography

At the inclusion visit for all patients and at M3 only for 50 patients.

Intervention Type OTHER

Fundus

At the inclusion visit for all patients and at M3 only for 50 patients.

Intervention Type OTHER

cardiac ultrasound scan

Only for 50 patients, 3 months after the initial cardiovascular event

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chu Dijon Bourogne

Dijon, , France

Site Status

Countries

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France

Other Identifiers

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MEILLON AOI 2017

Identifier Type: -

Identifier Source: org_study_id

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