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Recruiting NCT07100457

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

Observational Myocardial Ischemia-Reperfusion Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Blood Biomarker Profiling and Prognostic Follow-up.
Who it may be relevant to
Registry conditions: Myocardial Ischemia-Reperfusion Injury. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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 test Blood 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.

Primary outcome measures

  • Major Adverse Cardiovascular Events [Time frame: From enrollment to 44 months after reperfusion injury]
Secondary outcome measures (4)
  • 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)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Department of Cardiology, Zhongda Hospital, Southeast University — Nanjing

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. PMID 41223038

Identifiers

NCT: NCT07100457 · 2020ZDSYLL051-P01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗