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临床试验/NCT06542653
NCT06542653招募中不适用

Effect of PCI on Clinical Prognosis of Chronic Coronary Artery Occlusion

The First Affiliated Hospital with Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 258 人开始时间: 2023年9月17日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
258
试验地点
1
主要终点
major adverse cardiac cerebrovascular events (MACCE)

研究概览

简要总结

Coronary chronic total occlusions (CTOs) are considered to increase the risk of adverse clinical outcomes. The purpose of this study was to evaluate whether long-term clinical outcomes could be improved by successful percutaneous coronary intervention (PCI) over optimal medical therapy (OMT) in CTO patients.

详细描述

patients with CTO lesions undergoing PCI at the First Affiliated Hospital of Nanjing Medical University from January 2011 to December 2017 were enrolled. After someone were excluded due to CABG surgery, patients who met the enrollment criteria were divided into successful CTO-PCI group and CTO-OMT group based on the treatment received. The study primary endpoint was major adverse cardiac cerebrovascular events (MACCE), including cardiac death, recurrent myocardial infarction, unplanned revascularization, and stroke. The secondary endpoint was all-cause death.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with at least one coronary CTO lesion at our hospital in between January 2011 and December 2017

排除标准

  • (1) patients with ST-segment elevation myocardial infarction (STEMI)
  • (2)a history of coronary artery bypass grafting (CABG)
  • (3) cardiogenic shock
  • (4) malignant tumor. Patients were referred for PCI based on CTO-related symptoms or evidence of viability, or corresponding ischemia in the area of the CTO artery.

研究组 & 干预措施

CTO-PCI group

successful percutaneous coronary intervention (PCI)

干预措施: PCI (Procedure)

CTO-PCI group

successful percutaneous coronary intervention (PCI)

干预措施: OMT (Drug)

CTO-OMT group

optimal medical therapy (OMT)

干预措施: OMT (Drug)

结局指标

主要结局

major adverse cardiac cerebrovascular events (MACCE)

时间窗: January 2011 to December 2023

including cardiac death, recurrent myocardial infarction, unplanned revascularization, and stroke.

次要结局

  • all-cause death(January 2011 to December 2023)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chen Leilei

Director

The First Affiliated Hospital with Nanjing Medical University

研究点 (1)

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