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临床试验/NCT03874481
NCT03874481Unknown不适用

The Effect of Sleep Quality on Coronary Artery Disease and In Stent Restenosis

China National Center for Cardiovascular Diseases1 个研究点 分布在 1 个国家目标入组 958 人开始时间: 2018年11月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
958
试验地点
1
主要终点
In-stent restenosis

研究概览

简要总结

This is a cross-sectional and follow-up study. We analysis the relationship of sleep quality on coronary artery disease(CAD) and in stent restenosis(ISR). Further, we explore the mechanism of relationship between the sleep quality and CAD/ ISR by examining the biomarkers in the pathway of sleep-CAD/ISR.

详细描述

Background: Coronary artery disease (CAD) is the leading cause of mortality in the world. The important treatment of CAD is Percutaneous coronary intervention(PCI). However, in-stent-restenosis(ISR) is the major issue in the PCI. The factors of ISR include gender, age, diabetes, lipid ,obesity and so on.Recently, studies showed that sleep duration and sleep quality have effect on all of factors and have relationship with coronary artery calcification. We like to explore the relationship between sleep quality and CAD/ISR.

Aims:This is a cross-sectional and follow-up study. We analysis the relationship of sleep quality on coronary artery disease(CAD) and in stent restenosis(ISR). Further, we explore the mechanism of relationship between the sleep quality and CAD/ ISR by examining the biomarkers in the pathway of sleep-CAD/ISR.

Methods: We include patients who were diagnosed as CAD by coronary arteriography. Sleep duration and quality were evaluated from sleep questionnaire. During the 6 months and 9-12months, we follow up the patients who got PCI and get information of Major Adverse Cardiovascular Events (MACE) from follow-up questionnaire. On 9-12 months after PCI, coronary arteriography were produced in PCI patients. Biomarkers were tested during the follow-up.

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
30 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of Coronary artery disease
  • PCI patients in the follow-up
  • written informed consent

排除标准

  • Heart failure; renal failure; secondary hypertension;valvular heart disease ;Cancer;

结局指标

主要结局

In-stent restenosis

时间窗: 9-12 months from PCI

The rate of in stent restenosis

次要结局

  • MACE(6months, 12months)

研究者

发起方
China National Center for Cardiovascular Diseases
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Hongjian Wang

Principal Investigator

China National Center for Cardiovascular Diseases

研究点 (1)

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