MITOCARDIA: Role of Mitophagy in Myeloid Cells During Coronary Atherosclerosis.

Sponsor
Centre Hospitalier Universitaire Dijon (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05708547
Collaborator
(none)
50
1
24.9
2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Blood samples
  • Procedure: myocardial tissue samples
  • Other: Data collection

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Role of Mitophagy in Myeloid Cells During Coronary Atherosclerosis.
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2025
Anticipated Study Completion Date :
Mar 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Atheromatous coronary patients

patients scheduled for coronary artery bypass surgery with extracorporeal circulation

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

Non-atheratomous patients

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

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

Outcome Measures

Primary Outcome Measures

  1. Mitophagy level by flow cytometry [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chu Dijon Bourgogne Dijon France 21000

Sponsors and Collaborators

  • Centre Hospitalier Universitaire Dijon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier:
NCT05708547
Other Study ID Numbers:
  • NUGUYEN AOI 2022
First Posted:
Feb 1, 2023
Last Update Posted:
Feb 1, 2023
Last Verified:
Jan 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 1, 2023