NCT05708547

Brief Summary

Atherosclerosis (deposition of a plaque essentially composed of lipids on the artery walls) is a frequent condition and is a leading cause of death worldwide. In addition to the long-established risk factors such as age, hypertension, diabetes or sedentary lifestyle, it has been demonstrated that immune cells can participate in the genesis of atherosclerotic plaques through metabolic and mitochondrial reprogramming. A non-invasive marker of this immune reprogramming has yet to be identified. Through the comparison of a group of atheromatous patients and a group of non-atheromatous patients, this study aims to evaluate this reprogramming phenomenon using a novel non-invasive method. This monocentric interventional study will take place at the Dijon Bourgogne University Hospital and will include 50 patients divided into 2 groups: "atheromatous coronary patients" and "non-atheromatous patients". The duration of participation in this study is 1 month. This study is based on usually performed procedures. Only blood samples will be taken on a catheter usually used during any cardiac surgery in addition to the medical care that is provided during hospitalization.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 1, 2023

Completed
10 months until next milestone

Study Start

First participant enrolled

November 14, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2025

Completed
Last Updated

November 21, 2025

Status Verified

November 1, 2025

Enrollment Period

1.9 years

First QC Date

January 23, 2023

Last Update Submit

November 18, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mitophagy level by flow cytometry

    Average fluorescence corresponding to PINK1-AF488 intracellular labelling (mitophagy checkpoint) in conventional (CD33+, CD66b-, CD14++, CD16-), intermediate (CD33+, CD66-, CD14++, CD16+), or non-conventional (CD33+, CD66b-, CD14+, CD16++) monocytes.

    Before the introduction of extracorporeal circulation.

Study Arms (2)

Atheromatous coronary patients

patients scheduled for coronary artery bypass surgery with extracorporeal circulation

Biological: Blood samplesProcedure: myocardial tissue samplesOther: Data collection

Non-atheratomous patients

Patients scheduled for valve or ascending aorta surgery with extracorporeal circulation without coronary lesion or peripheral arterial disease

Biological: Blood samplesProcedure: myocardial tissue samplesOther: Data collection

Interventions

Blood samplesBIOLOGICAL

at the beginning of the extracorporeal circulation, at the end of the extracorporeal circulation and at D1

Atheromatous coronary patientsNon-atheratomous patients

use of usually harvested right auricular tissue

Atheromatous coronary patientsNon-atheratomous patients

pre-operative data: demographic data, severity scores, co-morbidities, treatments administered, collection of the presence and stage of arteriosclerotic disease, SYNTAX score Collection of data on the procedure Data from the clinical evaluation and daily biological examinations until D7 data from the follow-up consultation between D30 and D60: late complications, total length of stay in intensive care and hospital

Atheromatous coronary patientsNon-atheratomous patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Atheromatous coronary patients and non-coronary patients

You may qualify if:

  • \- Person who provides oral consent
  • Group 1:
  • \- Patient scheduled for cardiac bypass surgery (isolated procedure) with extracorporeal circulation
  • Group 2:
  • Patient scheduled for valve ou ascending aorta surgery with extracorporeal circulation
  • No coronary lesion
  • No peripheral arterial disease (limbs, carotids, aortic aneurysm)

You may not qualify if:

  • Person not affiliated with national health care system
  • Medication that alters mitochondrial function (Chloroquine, hydroxychloroquine, rapamycin, carbamazepine, resveratrol, sildenafil)
  • Person under a legal protection measure (curatorship, guardianship, tutorship)
  • Pregnant, parturient or breastfeeding women
  • Major unable to express consent
  • Minor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Dijon Bourgogne

Dijon, 21000, France

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Blood Specimen CollectionData Collection

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesEpidemiologic MethodsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2023

First Posted

February 1, 2023

Study Start

November 14, 2023

Primary Completion

October 16, 2025

Study Completion

October 16, 2025

Last Updated

November 21, 2025

Record last verified: 2025-11

Locations