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临床试验/NCT07100457
NCT07100457招募中不适用

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

Southeast University, China1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年9月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
Major Adverse Cardiovascular Events

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Major Adverse Cardiovascular Events

时间窗: 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.

次要结局

  • Serum IL-1α Level(Baseline (within 24 hours after confirmed myocardial ischemia-reperfusion injury))
  • Serum IL-1β Level(Baseline (within 24 hours after confirmed myocardial ischemia-reperfusion injury))
  • Plasma Malondialdehyde (MDA) Level(Baseline (within 24 hours after confirmed myocardial ischemia-reperfusion injury))
  • Plasma Hydrogen Peroxide (H₂O₂) Level(Baseline (within 24 hours after confirmed myocardial ischemia-reperfusion injury))

研究者

发起方
Southeast University, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Genshan Ma

Director of Cardiovascular Medicine & Deputy Director of Cardiovascular Disease Research Institute, Zhongda Hospital Southeast University; Professor (Level-II); Chief Physician; PhD Advisor; Chairman, Cardiovascular Society of Jiangsu Medical Association

Southeast University, China

研究点 (1)

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