Retinal Microvascular Network and Coronary Revascularization Surgery at the Dijon University Hospital

NCT ID: NCT05315349

Last Updated: 2025-07-30

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

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-07

Study Completion Date

2025-04-28

Brief Summary

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When coronary artery disease cannot be treated with medication, revascularization surgery can be performed. Although there have been many advances in recent years, this surgery is still associated with a high incidence of cardiovascular complications.

These complications are more frequent in patients with microscopic vessel damage. In clinical practice, microvascular status is difficult to characterize. Several models have been proposed, but they remain imprecise and are difficult to reproduce.

However, the study of the retinal microvascular network has recently emerged as a promising model. It is simple, quick and non-invasive thanks to the use of photographs or CT scans of the fundus (by optical coherence tomography angiography = OCT-A). Thus, the retinal vasculature is very often presented as an in vivo access that provides a window into systemic peripheral vasculature.

Despite the systematic assessment of cardiovascular risk by the usual risk factors (diabetes, hypertension, sex, etc.), risk stratification remains imperfect in coronary revascularization surgery and remains associated with a high incidence of complications, the most frequent being acute kidney injury (AKI).

Preoperative screening for retinal microvascular data could improve surgical risk stratification and better predict the potential occurrence of severe renal complications. Patient management could thus tailored to avoid such complications.

The main objective of the study is to investigate, in patients scheduled for coronary revascularization surgery with extracorporeal circulation, the discriminative capacity of retinal vascular density to predict the occurrence of AKI within 7 days after surgery.

Detailed Description

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Conditions

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Myocardial Revascularization Surgery With Extracorporeal Circulation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Patient requiring cardiac surgery for myocardial revascularization

Group Type EXPERIMENTAL

Complete ophthalmological check-up

Intervention Type OTHER

Preoperatively, 3 to 7 days after surgery and 1 to 2 months after surgery: fundus, optical coherence tomography angiography (OCT-A)

Blood sampling

Intervention Type BIOLOGICAL

Preoperatively and on Day 1 of surgery: 6 tubes of approximately 5 ml each, i.e. 30 ml

Interventions

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Complete ophthalmological check-up

Preoperatively, 3 to 7 days after surgery and 1 to 2 months after surgery: fundus, optical coherence tomography angiography (OCT-A)

Intervention Type OTHER

Blood sampling

Preoperatively and on Day 1 of surgery: 6 tubes of approximately 5 ml each, i.e. 30 ml

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Adult patient who has given oral, free and informed consent
* Patient who is to undergo cardiac surgery for myocardial revascularization (coronary bypass surgery) with extracorporeal circulation at the Dijon University Hospital

Exclusion Criteria

* Patient not covered by national health insurance
* Patient subject to a measure of legal protection (curatorship, guardianship)
* Acute circulatory collapse prior to surgery (amine, inotrope, circulatory assistance) preventing preoperative OCT-A
* Patient with macular disease (age-related macular degeneration, diabetic maculopathy, vascular occlusion)
* Pregnant, parturient or breastfeeding women
* Adult unable to express consent
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 Bourgogne

Dijon, , France

Site Status

Countries

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France

Other Identifiers

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ARNOULD 2021

Identifier Type: -

Identifier Source: org_study_id

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