Myocardial Ischemia-Reperfusion InjuryNCT07100457
OR6A2 on Monocytes and Cardiovascular Outcomes in Myocardial Ischemia-Reperfusion Injury
An observational study of Myocardial Ischemia-Reperfusion Injury, run by Southeast University, China at 1 site in China.
Trial summary
This study examines how the interaction between octanal (an OR6A2 receptor activator) and OR6A2 expression influences inflammation and clinical outcomes in Myocardial Ischemia-Reperfusion Injury patients. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Myocardial Ischemia-Reperfusion Injury
- What is being tested?
- Blood Biomarker Profiling and Prognostic Follow-up
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2019to 30 Aug 2027
- How long will I take part?
- 44 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of consecutively enrolled participants with myocardial ischemia-reperfusion injury who are recruited from the Department of Cardiology at Zhongda Hospital, Southeast University, China.
Who may be able to join
- Acute myocardial infarction (AMI) patients with angiographically-confirmed coronary artery disease undergoing primary percutaneous coronary intervention (PCI), and subsequently diagnosed with protocol-defined myocardial ischemia-reperfusion injury during the post-PCI period.
- Age 18-90 years inclusive.
Who cannot join
- Active systemic infections.
- Advanced heart failure (NYHA class III-IV).
- Acute cerebrovascular conditions.
- Active myocarditis.
- cardiomyopathy.
- Refractory ventricular tachycardia/fibrillation.
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- Diagnosis/concurrent treatment for malignancy within 5 years (except non-melanoma skin cancer/carcinoma in situ).
- Severe renal insufficiency (estimated glomerular filtration rate [eGFR] <30 mL/min/1.73m2 or dialysis dependence).
- Child-Pugh class C hepatic dysfunction.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Cardiology, Zhongda Hospital, Southeast University
Nanjing, Jiangsu, 210009
Tingting Xiao, M.D., +86 16605198956, 230249327@seu.edu.cn
About this study
Official title: Association of OR6A2 Expression on Monocytes With Inflammation and Major Adverse Cardiovascular Events in Myocardial Ischemia-Reperfusion Injury
This study examines how the interaction between octanal (an OR6A2 receptor activator) and OR6A2 expression influences inflammation and clinical outcomes in Myocardial Ischemia-Reperfusion Injury patients. We analyze two key relationships: 1) The octanal-OR6A2 pathway's association with systemic oxidative stress/inflammatory biomarkers, and 2) How OR6A2 expression patterns on monocyte subtypes and plasma octanal levels correlate with major cardiovascular events. Patients undergoing this post-revascularization injury provided blood samples for OR6A2/octanal/inflammation measurements. IR Injury patients underwent 44-month clinical follow-up. Results may identify biological markers for personalized risk assessment after revascularization therapies. Ethics approval: Zhongda Hospital #2020ZDSYLL051-P01.
- Conditions
- Myocardial Ischemia-Reperfusion Injury
- Being tested
- Blood Biomarker Profiling and Prognostic Follow-up
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Biomarker Profiling and Prognostic Follow-upDiagnostic test
Peripheral venous blood collection for in-vitro quantification of serum biomarkers (including octanal, OR6A2, and inflammatory mediators) via mass spectrometry/ELISA/flow cytometry, coupled with longitudinal surveillance of Major Adverse Cardiovascular Events (MACEs) using hospital records, patient interviews, and adjudicated endpoint verification during scheduled follow-up visits.
| Study group | Role | What they receive |
|---|---|---|
| Patients With Myocardial Ischemia-Reperfusion Injury | Not described Receives: Diagnostic Test: Blood Biomarker Profiling and Prognostic Follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiovascular Events
Major Adverse Cardiovascular Events (MACEs) defined as the composite endpoint of recurrent acute myocardial infarction, cardiac death, stroke, hospitalization for unstable angina, or unplanned coronary revascularization.
Measured: From enrollment to 44 months after reperfusion injury
Secondary outcomes (4)
Serum IL-1α Level
Units: pg/mL
Measured: Baseline (within 24 hours after confirmed myocardial ischemia-reperfusion injury)
Serum IL-1β Level
Units: pg/mL
Measured: Baseline (within 24 hours after confirmed myocardial ischemia-reperfusion injury)
Plasma Malondialdehyde (MDA) Level
Units: μmol/L
Measured: Baseline (within 24 hours after confirmed myocardial ischemia-reperfusion injury)
Plasma Hydrogen Peroxide (H₂O₂) Level
Units: μmol/L
Measured: Baseline (within 24 hours after confirmed myocardial ischemia-reperfusion injury)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start1 Sep 2019
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
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 Myocardial Ischemia-Reperfusion InjuryStudies of the same condition, open and under way.
- 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
- 200 participants (estimated)
- Target duration
- 44 Months
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Genshan Ma, Southeast University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07100457
- Sponsor's protocol ID
- 2020ZDSYLL051-P01
- Status last verified
- Jul 2025
- First submitted
- 24 Jul 2025
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Zhang Y, Xiao T, Ding J, Jin H, Wu Y, Villamil OIRC, Wang D, Yang M, Cai J, Ma G, Lu W. Targeting olfactory receptor 2 on monocytes for cardioprotection against myocardial ischaemia-reperfusion injury via NR4A1-mediated mitochondrial fission. Cardiovasc Res. 2025 Dec 31;121(17):2759-2776. doi: 10.1093/cvr/cvaf232.
PubMed 41223038
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of OR6A2 Expression on Monocytes With Inflammation and Major Adverse Cardiovascular Events in Myocardial Ischemia-Reperfusion Injury
- ClinicalTrials.gov ID
- NCT07100457
- Acronym / sponsor ID
- 2020ZDSYLL051-P01
- Conditions
- Myocardial Ischemia-Reperfusion Injury
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 3 Aug 2025 (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.
This study examines how the interaction between octanal (an OR6A2 receptor activator) and OR6A2 expression influences inflammation and clinical outcomes in Myocardial Ischemia-Reperfusion Injury patients. We analyze two key relationships: 1) The octanal-OR6A2 pathway's association with systemic oxidative stress/inflammatory biomarkers, and 2) How OR6A2 expression patterns on monocyte subtypes and plasma octanal levels correlate with major cardiovascular events. Patients undergoing this post-revascularization injury provided blood samples for OR6A2/octanal/inflammation measurements. IR Injury patients underwent 44-month clinical follow-up. Results may identify biological markers for personalized risk assessment after revascularization therapies. Ethics approval: Zhongda Hospital #2020ZDSYLL051-P01.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 44 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients With Myocardial Ischemia-Reperfusion Injury | – | Diagnostic Test: Blood Biomarker Profiling and Prognostic Follow-up |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of consecutively enrolled participants with myocardial ischemia-reperfusion injury who are recruited from the Department of Cardiology at Zhongda Hospital, Southeast University, China.
Key inclusion criteria (2 listed)
- Acute myocardial infarction (AMI) patients with angiographically-confirmed coronary artery disease undergoing primary percutaneous coronary intervention (PCI), and subsequently diagnosed with protocol-defined myocardial ischemia-reperfusion injury during the post-PCI period.
- Age 18-90 years inclusive.
Key exclusion criteria (9 listed)
- Active systemic infections.
- Advanced heart failure (NYHA class III-IV).
- Acute cerebrovascular conditions.
- Active myocarditis.
- cardiomyopathy.
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 Biomarker Profiling and Prognostic Follow-upPeripheral venous blood collection for in-vitro quantification of serum biomarkers (including octanal, OR6A2, and inflammatory mediators) via mass spectrometry/ELISA/flow cytometry, coupled with longitudinal surveillance of Major Adverse Cardiovascular Events (MACEs) using hospital records, patient interviews, and adjudicated endpoint verification during scheduled follow-up visits. | Diagnostic test | Patients With Myocardial Ischemia-Reperfusion Injury |
Primary outcome
Major Adverse Cardiovascular Events
Time frame: From enrollment to 44 months after reperfusion injury
Major Adverse Cardiovascular Events (MACEs) defined as the composite endpoint of recurrent acute myocardial infarction, cardiac death, stroke, hospitalization for unstable angina, or unplanned coronary revascularization.
4 secondary outcomes
Serum IL-1α Level
Time frame: Baseline (within 24 hours after confirmed myocardial ischemia-reperfusion injury)
Serum IL-1β Level
Time frame: Baseline (within 24 hours after confirmed myocardial ischemia-reperfusion injury)
Plasma Malondialdehyde (MDA) Level
Time frame: Baseline (within 24 hours after confirmed myocardial ischemia-reperfusion injury)
Plasma Hydrogen Peroxide (H₂O₂) Level
Time frame: Baseline (within 24 hours after confirmed myocardial ischemia-reperfusion injury)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Derived from this study: PubMed 41223038Zhang Y, Xiao T, Ding J, Jin H, Wu Y, Villamil OIRC, Wang D, Yang M, Cai J, Ma G, Lu W. Targeting olfactory receptor 2 on monocytes for cardioprotection against myocardial ischaemia-reperfusion injury via NR4A1-mediated mitochondrial fission. Cardiovasc Res. 2025 Dec 31;121(17):2759-2776. doi: 10.1093/cvr/cvaf232.
- Individual participant dataSharing planned: Yes
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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.
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 Myocardial Ischemia-Reperfusion Injury, run by Southeast University, China at 1 site in China.
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 2 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 3 Aug 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenbin Lu, PhD (+86 13605185175, 101012092@seu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiovascular Events (time frame: From enrollment to 44 months after reperfusion injury). 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 NCT07100457, 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 3 Aug 2025.