- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05708547
Role of Mitophagy in Myeloid Cells During Coronary Atherosclerosis. (MITOCARDIA)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Dijon, France, 21000
- CHU Dijon Bourgogne
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Atheromatous coronary patients
patients scheduled for coronary artery bypass surgery with extracorporeal circulation
|
at the beginning of the extracorporeal circulation, at the end of the extracorporeal circulation and at D1
use of usually harvested right auricular tissue
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
|
|
Non-atheratomous patients
Patients scheduled for valve or ascending aorta surgery with extracorporeal circulation without coronary lesion or peripheral arterial disease
|
at the beginning of the extracorporeal circulation, at the end of the extracorporeal circulation and at D1
use of usually harvested right auricular tissue
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mitophagy level by flow cytometry
Time Frame: Before the introduction of extracorporeal circulation.
|
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.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Vascular Diseases
- Cardiovascular Diseases
- Heart Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Disease
- Myocardial Ischemia
- Coronary Artery Disease
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Specimen Handling
- Clinical Laboratory Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Punctures
- Surgical Procedures, Operative
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Blood Specimen Collection
- Data Collection
Other Study ID Numbers
- NUGUYEN AOI 2022
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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