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临床试验/NCT03066141
NCT03066141已完成不适用

The Prevalence and Influence of Obstructive Sleep Apnea in Coronary Artery Disease in Modern Age: Findings in A Large Cohort Study

Chinese Pulmonary Vascular Disease Research Group1 个研究点 分布在 1 个国家目标入组 255 人开始时间: 2017年2月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
255
试验地点
1
主要终点
Association of apnea-hypopnea index (AHI) between obstructive sleep apnea and severity of coronary artery disease

研究概览

简要总结

It is widely accepted that coronary artery disease (CAD) is related to a high mortality. It is predicted that an increase of approximately 21.3 million cardiovascular events and 7.7 million cardiovascular deaths over 2010 to 2030 in China.1 Male sex, diabetes mellitus, hypertension, hypercholesterolemia, obesity and smoking are all traditionally considered as risk factors for CAD. In recent decades, tremendous progress toward the prevention and treatment of traditional cardiovascular risk factors have helped decrease the morbidity and mortality from CAD, but the condition remains a major public health challenge worldwide. Looking into the other potential risk factors (OSA) for CAD, it may help to develop additional preventative strategies and further reduce the incidence and mortality of CAD.

详细描述

Before initiating the study, all potential subjects were invited to attend an educational program that explained the purpose and methodology of this study. After getting informed consent from patients, demographic data including age, sex, medical history (including comorbidities and risk factors), current medicine, lifestyle habits, height (cm), and weight (kg) were recorded, and body mass index (BMI) was calculated as weight divided by height squared (kilograms per square meter, kg/m2). The included subjects need to perform transthoracic echocardiography or provide an echocardiographic examination within one month. CAD diagnosis was determined based on the results of the coronary angiography, using stenosis 50% cutoffs considered have coronary diseases or not.

Consecutive patients of both sexes with coronary angiography from outpatient or inpatient departments of Fuwai Hospital were recruited into the study. The inclusion criteria were Chinese, aged 35 to 75 years with CAD verified by coronary angiography, and able to give informed written consent. The subjects were excluded if they had New York Heart Association Class III-IV degree with ejection fraction < 45%, severe pulmonary disease, significant psychiatric disease, or history of pharyngeal surgery for OSA or current use of CPAP treatment for OSA. They were also excluded if they declined to participate or were unable to provide informed consent.

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
35 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • aged 35 to 75 years with CAD
  • CAD was verified by coronary angiography

排除标准

  • Patients had New York Heart Association Class III-IV degree with ejection fraction < 45%
  • Severe pulmonary disease
  • Significant psychiatric disease
  • History of pharyngeal surgery for OSA or current use of CPAP treatment for OSA
  • Subjects declined to participate or were unable to provide informed consent.

结局指标

主要结局

Association of apnea-hypopnea index (AHI) between obstructive sleep apnea and severity of coronary artery disease

时间窗: 12 months

The apnea-hypopnea index (AHI) was calculated as the total number of apneas and hypopneas occurring per hour of sleep. And the severity of coronary artery disease was determined by Coronary angiography.

次要结局

  • The Prevalence of Obstructive Sleep Apnea in Coronary Artery Disease in China(12 months)

研究者

发起方
Chinese Pulmonary Vascular Disease Research Group
申办方类型
Other
责任方
Sponsor

研究点 (1)

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