Department of Cardiology, Zhongda Hospital, Southeast University
Nanjing, Jiangsu, 210009, China
Location status: Recruiting
Recruiting
NCT Number: NCT07100457
OR6A2 on Monocytes and Cardiovascular Outcomes 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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–90 year
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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.
Exclusion criteria
- Active systemic infections.
- Advanced heart failure (NYHA class III-IV).
- Acute cerebrovascular conditions.
- Active myocarditis.
- cardiomyopathy.
- Refractory ventricular tachycardia/fibrillation.
- 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.
Treatment and study plan
Blood Biomarker Profiling and Prognostic Follow-up
Diagnostic TestPeripheral 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.
Primary outcomes
-
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.
Secondary outcomes
-
Serum IL-1α Level
Time frame: Baseline (within 24 hours after confirmed myocardial ischemia-reperfusion injury)
Units: pg/mL
-
Serum IL-1β Level
Time frame: Baseline (within 24 hours after confirmed myocardial ischemia-reperfusion injury)
Units: pg/mL
-
Plasma Malondialdehyde (MDA) Level
Time frame: Baseline (within 24 hours after confirmed myocardial ischemia-reperfusion injury)
Units: μmol/L
-
Plasma Hydrogen Peroxide (H₂O₂) Level
Time frame: Baseline (within 24 hours after confirmed myocardial ischemia-reperfusion injury)
Units: μmol/L
Study contacts
Contact information is provided by the study sponsor or research team.
Wenbin Lu, PhD
CONTACT
Yahao Zhang, M.D.
CONTACT
Sponsors and collaborators
Lead sponsor
Southeast University, China
Other
Registry information
Official study title
Association of OR6A2 Expression on Monocytes With Inflammation and Major Adverse Cardiovascular Events in Myocardial Ischemia-Reperfusion Injury
Important dates
- Study start
- 2019
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Aug 3, 2025
- Registry last updated
- Aug 3, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.