Myocardial Revascularization Surgery With Extracorporeal CirculationMRCCNCT05315349
Retinal Microvascular Network and Coronary Revascularization Surgery at the Dijon University Hospital
A study testing Complete ophthalmological check-up and Blood sampling in people with Myocardial Revascularization Surgery With Extracorporeal Circulation, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Revascularization Surgery With Extracorporeal Circulation
- What is being tested?
- Complete ophthalmological check-up and Blood sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jun 2022to 28 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Being tested
- Complete ophthalmological check-up, Blood sampling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complete ophthalmological check-upOther
Preoperatively, 3 to 7 days after surgery and 1 to 2 months after surgery: fundus, optical coherence tomography angiography (OCT-A)
Blood samplingBiological
Preoperatively and on Day 1 of surgery: 6 tubes of approximately 5 ml each, i.e. 30 ml
| Study group | Role | What they receive |
|---|---|---|
| Patient requiring cardiac surgery for myocardial revascularization | Experimental | Not described Receives: Other: Complete ophthalmological check-up; Biological: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start7 Jun 2022
- Primary completion28 Apr 2025
- Study completion28 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial Revascularization Surgery With Extracorporeal CirculationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05315349
- Sponsor's protocol ID
- ARNOULD 2021
- Acronym
- MRCC
- Status last verified
- Jul 2025
- First submitted
- 30 Mar 2022
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retinal Microvascular Network and Coronary Revascularization Surgery at the Dijon University Hospital: Pilot Study
- ClinicalTrials.gov ID
- NCT05315349
- Acronym / sponsor ID
- MRCC / ARNOULD 2021
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 7 Jun 2022 (actual)
- Primary completion
- 28 Apr 2025 (actual)
- Study completion
- 28 Apr 2025 (actual)
- First posted
- 7 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient requiring cardiac surgery for myocardial revascularization | Experimental | Other: Complete ophthalmological check-up, Biological: Blood sampling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Complete ophthalmological check-upPreoperatively, 3 to 7 days after surgery and 1 to 2 months after surgery: fundus, optical coherence tomography angiography (OCT-A) | Other | Patient requiring cardiac surgery for myocardial revascularization |
| Blood samplingPreoperatively and on Day 1 of surgery: 6 tubes of approximately 5 ml each, i.e. 30 ml | Biological | Patient requiring cardiac surgery for myocardial revascularization |
Primary outcome
Acute Kidney Failure (AKI) rate based on the Kidney Disease Improving Global Outcomes (KDIGO) Criteria
Time frame: 7 days post-surgery
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complete ophthalmological check-up and Blood sampling in people with Myocardial Revascularization Surgery With Extracorporeal Circulation, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Kidney Failure (AKI) rate based on the Kidney Disease Improving Global Outcomes (KDIGO) Criteria (time frame: 7 days post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.