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Influence of Obstructive Sleep Apnea on the Severity of Coronary Artery Disease

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

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.

研究概览

地位

完全的

详细说明

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.

研究类型

观察性的

注册 (实际的)

255

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Beijing、中国、100037
        • Center of pulmonary vascular disease, Fuwai hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

35年 至 75年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

概率样本

研究人群

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.

描述

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
CAD with OSA
coronary artery disease with Obstructive sleep apnea
CAD without OSA
coronary artery disease without Obstructive sleep apnea

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Association of apnea-hypopnea index (AHI) between obstructive sleep apnea and severity of coronary artery disease
大体时间: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.
12 months

次要结果测量

结果测量
措施说明
大体时间
The Prevalence of Obstructive Sleep Apnea in Coronary Artery Disease in China
大体时间:12 months
The number of patients with Obstructive Sleep Apnea in Coronary Artery Disease in China
12 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 学习椅:Zhihong Liu, M.D、Fuwai Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年2月14日

初级完成 (实际的)

2019年8月29日

研究完成 (实际的)

2019年8月29日

研究注册日期

首次提交

2021年2月3日

首先提交符合 QC 标准的

2021年2月3日

首次发布 (实际的)

2021年2月5日

研究记录更新

最后更新发布 (实际的)

2021年2月5日

上次提交的符合 QC 标准的更新

2021年2月3日

最后验证

2019年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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