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

Recruiting

• Conditions: Myocardial Ischemia-Reperfusion Injury

• Registration Number: NCT07100457
• Lead Sponsor: Southeast University, China

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-01
• Status Verified: 2025-07
• Study First Submitted: 2025-07-24
• Study First Submitted QC: 2025-07-30
• Last Update Submitted: 2025-07-30
• Study First Posted: 2025-08-03
• Last Update Posted: 2025-08-03
• Primary Completion: 2027-08-30
• Study Completion: 2027-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major Adverse Cardiovascular Events	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.

Secondary Outcome Measures

Name	Time	Method
Serum IL-1α Level	Baseline (within 24 hours after confirmed myocardial ischemia-reperfusion injury)	Units: pg/mL
Serum IL-1β Level	Baseline (within 24 hours after confirmed myocardial ischemia-reperfusion injury)	Units: pg/mL
Plasma Malondialdehyde (MDA) Level	Baseline (within 24 hours after confirmed myocardial ischemia-reperfusion injury)	Units: μmol/L
Plasma Hydrogen Peroxide (H₂O₂) Level	Baseline (within 24 hours after confirmed myocardial ischemia-reperfusion injury)	Units: μmol/L

Trial Locations

Locations (1)

Department of Cardiology, Zhongda Hospital, Southeast University; 🇨🇳 Nanjing, Jiangsu, China