Role of Mitophagy in Myeloid Cells During Coronary Atherosclerosis.

Coronary Atherosclerosis Clinical Trial

— MITOCARDIA  

Official title:

Role of Mitophagy in Myeloid Cells During Coronary Atherosclerosis.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05708547
• Other study ID #: NUGUYEN AOI 2022
• Status: Recruiting
• Start date: November 14, 2023
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire Dijon
• Contact: Pierre-Alain BAHR
• Phone: 03 80 29 30 21
• Email: pierre-alain.bahr[@]chu-dijon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Coronary Atherosclerosis
• Myocardial Ischemia

Intervention

Biological:
• Blood samples
at the beginning of the extracorporeal circulation, at the end of the extracorporeal circulation and at D1

Procedure:
• myocardial tissue samples
use of usually harvested right auricular tissue

Other:
• Data collection
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

Locations

Country	Name	City	State
France	Chu Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.