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OR6A2 on Monocytes and Cardiovascular Outcomes in Myocardial Ischemia-Reperfusion Injury

Association of OR6A2 Expression on Monocytes With Inflammation and Major Adverse Cardiovascular Events in Myocardial Ischemia-Reperfusion Injury

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07100457
Enrollment
200
Registered
2025-08-03
Start date
2019-09-01
Completion date
2027-08-30
Last updated
2025-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Ischemia-Reperfusion Injury

Brief 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. 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.

Interventions

DIAGNOSTIC_TESTBlood Biomarker Profiling and Prognostic Follow-up

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.

Sponsors

Southeast University, China
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

1. 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. 2. Age 18-90 years inclusive.

Exclusion criteria

1. Active systemic infections. 2. Advanced heart failure (NYHA class III-IV). 3. Acute cerebrovascular conditions. 4. Active myocarditis. 5. cardiomyopathy. 6. Refractory ventricular tachycardia/fibrillation. 7. Diagnosis/concurrent treatment for malignancy within 5 years (except non-melanoma skin cancer/carcinoma in situ). 8. Severe renal insufficiency (estimated glomerular filtration rate \[eGFR\] \<30 mL/min/1.73m2 or dialysis dependence). 9. Child-Pugh class C hepatic dysfunction.

Design outcomes

Primary

MeasureTime frameDescription
Major Adverse Cardiovascular EventsFrom enrollment to 44 months after reperfusion injuryMajor 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.

Secondary

MeasureTime frameDescription
Serum IL-1α LevelBaseline (within 24 hours after confirmed myocardial ischemia-reperfusion injury)Units: pg/mL
Serum IL-1β LevelBaseline (within 24 hours after confirmed myocardial ischemia-reperfusion injury)Units: pg/mL
Plasma Malondialdehyde (MDA) LevelBaseline (within 24 hours after confirmed myocardial ischemia-reperfusion injury)Units: μmol/L
Plasma Hydrogen Peroxide (H₂O₂) LevelBaseline (within 24 hours after confirmed myocardial ischemia-reperfusion injury)Units: μmol/L

Countries

China

Contacts

Primary ContactWenbin Lu, PhD
101012092@seu.edu.cn+86 13605185175
Backup ContactYahao Zhang, M.D.
zhyh626@163.com+86 13523060936

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026