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临床试验/NCT06156319
NCT06156319尚未招募不适用

A Multicentre Cohort Study on the Effect of Clonal Hematopoiesis on Prognosis in Patients With Myocardial Infarction Based on Residual Inflammation Risk

Yang Jing0 个研究点目标入组 500 人开始时间: 2023年12月20日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
500
主要终点
MACE

研究概览

简要总结

This is an observational study without intervention. It is planned to include 500 patients with AMI from October 2023 to July 2026.The study was divided into three parts. Part I: To investigate the effect of CHIP on renal insufficiency in AMI patients.

Part two: To investigate the effect of CHIP on cardiovascular outcomes in patients with AMI complicated with CKD stage II-IV nephropathy. Part three: To investigate the effects of CHIP on cardiovascular and renal outcomes in AMI patients with ESRD. Study endpoint: Primary end points: all-cause death, cardiac death, and nonfatal myocardial infarction. Secondary endpoints: angina pectoris requiring hospitalization, nonfatal stroke, and nonfatal heart failure.

详细描述

This is an observational study without intervention. It is planned to include 500 patients with AMI from October 2023 to July 2026.The study was divided into three parts. Part I: To investigate the effect of CHIP on renal insufficiency in AMI patients.

Patients with confirmed AMI were divided into two groups based on eGFR values:

AMI+ normal renal function group (eGFR≥90 ml/min); AMI+ renal dysfunction group (eGFR < 90 ml/min). Main outcome measures: CHIP carrying frequency, expression levels of IL-1β, IL-6, CRP, TNF-α, NLRP3 and other inflammatory factors.

Part two: To investigate the effect of CHIP on cardiovascular outcomes in patients with AMI complicated with CKD stage II-IV nephropathy. Patients with confirmed AMI complicated with CKD stage II-IV were divided into two groups according to CHIP sequencing results: CHIP group: Patients diagnosed with AMI combined with CKD stage II-IV underwent PCI and were identifi ed as CHIP carriers by gene targeted sequencing. Non-chip group: Patients diagnosed with AMI combined with CKD stage II-IV underwent PCI and were identified as non-CHIP carriers by gene targeted sequencing. Study endpoint: Primary endpoints: all-cause death, cardiac death, nonfatal myocardial infarction,50% decrease in eGFR, or ESKD. Secondary endpoints: angina pectoris requiring hospitalization, nonfatal stroke, and nonfatal heart failure. Part III: To investigate the effects of CHIP on cardiovascular and renal outcomes in AMI patients with ESRD. Patients with confirmed AMI combined with ESRD were divided into two groups according to CHIP sequencing results: CHIP group: Patients diagnosed with AMI combined with ESRD underwent PCI and were identified as CHIP carriers by gene targeted sequencing. Non-chip group: Patients diagnosed with AMI combined with ESRD underwent PCI and were identified as non-CHIP carriers by gene targeted sequencing. Study endpoint: Primary end points: all-cause death, cardiac death, and nonfatal myocardial infarction. Secondary endpoints: angina pectoris requiring hospitalization, nonfatal stroke, and nonfatal heart failure.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with AMI received PCI.

排除标准

  • patients with severe heart disease, severe liver and kidney insufficiency, pregnancy, etc.

结局指标

主要结局

MACE

时间窗: 2 years

all-cause death, cardiac death, and nonfatal myocardial infarction.

次要结局

未报告次要终点

研究者

发起方
Yang Jing
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yang Jing

physician

Chongqing Emergency Medical Center

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