Coronary AtherosclerosisMITOCARDIANCT05708547
Role of Mitophagy in Myeloid Cells During Coronary Atherosclerosis.
An observational study of Coronary Atherosclerosis, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Atherosclerosis
- What is being tested?
- Blood samples, myocardial tissue samples and Data collection
- Type of treatment
- Surgery or procedure
- How many people
- 61 participants
- Where
- 1 siteFrance
- Study dates
- 14 Nov 2023to 16 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Atheromatous coronary patients and non-coronary patients
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Coronary Atherosclerosis
- Being tested
- Blood samples, myocardial tissue samples, Data collection
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesBiological
at the beginning of the extracorporeal circulation, at the end of the extracorporeal circulation and at D1
myocardial tissue samplesProcedure or surgery
use of usually harvested right auricular tissue
Data collectionOther
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
| Study group | Role | What they receive |
|---|---|---|
| Atheromatous coronary patients | patients scheduled for coronary artery bypass surgery with extracorporeal circulation Receives: Biological: Blood samples; Procedure: myocardial tissue samples; Other: Data collection | |
| Non-atheratomous patients | Patients scheduled for valve or ascending aorta surgery with extracorporeal circulation without coronary lesion or peripheral arterial disease Receives: Biological: Blood samples; Procedure: myocardial tissue samples; Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before the introduction of extracorporeal circulation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start14 Nov 2023
- Primary completion16 Oct 2025
- Study completion16 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary AtherosclerosisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05708547
- Sponsor's protocol ID
- NUGUYEN AOI 2022
- Acronym
- MITOCARDIA
- Status last verified
- Nov 2025
- First submitted
- 23 Jan 2023
- Last updated
- 21 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liao M, Men L, Gong M, Li Y, Wang Y, Xu D, Luan J, Zhou H, Liu M, Chen M. Mitophagy: a novel avenue for herbal medicines alleviating myocardial ischemia/reperfusion injury. Apoptosis. 2025 Dec;30(11-12):2676-2693. doi: 10.1007/s10495-025-02178-x. Epub 2025 Sep 12.
PubMed 40938522
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Mitophagy in Myeloid Cells During Coronary Atherosclerosis.
- ClinicalTrials.gov ID
- NCT05708547
- Acronym / sponsor ID
- MITOCARDIA / NUGUYEN AOI 2022
- Conditions
- Coronary Atherosclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 14 Nov 2023 (actual)
- Primary completion
- 16 Oct 2025 (actual)
- Study completion
- 16 Oct 2025 (actual)
- First posted
- 1 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atheromatous coronary patients | – | Biological: Blood samples, Procedure: myocardial tissue samples, Other: Data collectionpatients scheduled for coronary artery bypass surgery with extracorporeal circulation |
| Non-atheratomous patients | – | Biological: Blood samples, Procedure: myocardial tissue samples, Other: Data collectionPatients scheduled for valve or ascending aorta surgery with extracorporeal circulation without coronary lesion or peripheral arterial disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Atheromatous coronary patients and non-coronary patients
Key inclusion criteria (7 listed)
- Person who provides oral consent
- Patient scheduled for cardiac bypass surgery (isolated procedure) with extracorporeal circulation
- Patient scheduled for valve ou ascending aorta surgery with extracorporeal circulation
- No coronary lesion
- No peripheral arterial disease (limbs, carotids, aortic aneurysm)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplesat the beginning of the extracorporeal circulation, at the end of the extracorporeal circulation and at D1 | Biological | Atheromatous coronary patients, Non-atheratomous patients |
| myocardial tissue samplesuse of usually harvested right auricular tissue | Procedure or surgery | Atheromatous coronary patients, Non-atheratomous patients |
| Data collectionpre-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 | Other | Atheromatous coronary patients, Non-atheratomous patients |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Derived from this study: PubMed 40938522Liao M, Men L, Gong M, Li Y, Wang Y, Xu D, Luan J, Zhou H, Liu M, Chen M. Mitophagy: a novel avenue for herbal medicines alleviating myocardial ischemia/reperfusion injury. Apoptosis. 2025 Dec;30(11-12):2676-2693. doi: 10.1007/s10495-025-02178-x. Epub 2025 Sep 12.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Atherosclerosis, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mitophagy level by flow cytometry (time frame: Before the introduction of extracorporeal circulation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05708547, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.