Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05708547
Other study ID # NUGUYEN AOI 2022
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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.
See also
  Status Clinical Trial Phase
Withdrawn NCT02265146 - ORACLE-NIRS: Lipid cORe Plaque Association With CLinical Events: a Near-InfraRed Spectroscopy Study
Completed NCT02335086 - DNA Damage & Repair Proteins In Patients With Atherosclerotic Coronary Artery Disease N/A
Completed NCT00811772 - Trial of Drug Eluting Stent Versus Bare Metal Stent to Treat Coronary Artery Stenosis N/A
Recruiting NCT03322332 - Adipokines of Epicardial Adipose Tissue and Atherosclerosis of Coronary Arteries N/A
Completed NCT02305953 - Cytokines and Vascular Inflammation in Psoriasis N/A
Completed NCT01642173 - Assessment of Coronary Plaque Composition Using Optical Coherence Tomography Phase 1
Completed NCT02316782 - Bifurcation Lesion Analysis and STenting / BLAST
Completed NCT00548613 - Combination Stem Cell (MESENDO) Therapy for Utilization and Rescue of Infarcted Myocardium Phase 1
Terminated NCT00243308 - Serp-1 for the Treatment of Acute Coronary Syndrome Phase 2
Recruiting NCT05105750 - A Comparative Study of Indobufen and Aspirin in Patients With Coronary Atherosclerosis Phase 4
Completed NCT01722214 - Trial on the Effect of Adalimumab on Vascular Inflammation in Patients With Psoriasis Phase 4
Terminated NCT01030328 - AFRICA: Atorvastatin Plus Fenofibric Acid (TriLipix) in the Reduction of Intermediate Coronary Atherosclerosis Phase 3
Suspended NCT00790764 - Phase II Combination Stem Cell Therapy for the Treatment of Severe Coronary Ischemia(CI) Phase 2
Active, not recruiting NCT01061398 - CT-FIRST: Cardiac Computed Tomography Versus Stress Imaging For Initial Risk STratification N/A
Completed NCT00431977 - Validation Study of Coronary CT Angiography as a Screening Tool in Asymptomatic Diabetes N/A
Completed NCT00431717 - Coronary Computed Tomography Angiography and SPECT in Asymptomatic Diabetes N/A
Recruiting NCT00155350 - Treatment of Coronary Atherosclerosis by Insulin Sensitizers in Insulin-Resistant Patients Phase 4
Terminated NCT02440646 - Natural History of Coronary Atherosclerosis in Real-World Stable Chest Pain Patients Underwent Computed Tomography Angiography in Comparison With Invasive Multimodality Imaging
Completed NCT02576704 - Prognostic Value of Myocardial Perfusion Heterogeneity in Normal SPECT Studies N/A
Terminated NCT01268319 - CANARY: Coronary Assessment by Near-infrared of Atherosclerotic Rupture-prone Yellow N/A