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

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

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Revascularization Surgery With Extracorporeal Circulation
• Intervention / Treatment: Other: Complete ophthalmological check-up; Biological: Blood sampling

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Dijon, France, 21000
    • CHU Dijon Bourgogne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient requiring cardiac surgery for myocardial revascularization	Other: 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); Biological: Blood sampling; Preoperatively and on Day 1 of surgery: 6 tubes of approximately 5 ml each, i.e. 30 ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute Kidney Failure (AKI) rate based on the Kidney Disease Improving Global Outcomes (KDIGO) Criteria	Discriminative ability of mean retinal vascular density to predict acute kidney injury (defined by the KDIGO criteria) following coronary artery bypass grafting with extracorporeal circulation	7 days post-surgery

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2022
• Primary Completion (Actual): April 28, 2025
• Study Completion (Actual): April 28, 2025

Study Registration Dates

• First Submitted: March 30, 2022
• First Submitted That Met QC Criteria: March 30, 2022
• First Posted (Actual): April 7, 2022

Study Record Updates

• Last Update Posted (Actual): July 30, 2025
• Last Update Submitted That Met QC Criteria: July 25, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: ARNOULD 2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No