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

NCT05315349 | Completed

• 1 other identifier: ARNOULD 2021
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myocardial Revascularization Surgery With Extracorporeal Circulation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Patient requiring cardiac surgery for myocardial revascularization

EXPERIMENTAL

Other: Complete ophthalmological check-up; Biological: Blood sampling

Interventions

Complete ophthalmological check-up OTHER

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

Patient requiring cardiac surgery for myocardial revascularization

Blood sampling BIOLOGICAL

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

Patient requiring cardiac surgery for myocardial revascularization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourgogne

Dijon, 21000, France

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2022
• First Posted: April 7, 2022
• Study Start: June 7, 2022
• Primary Completion: April 28, 2025
• Study Completion: April 28, 2025
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)