Evaluation of Association Between Obstructive Sleep Apnea and the Severity of Coronary Artery Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03066141|
Recruitment Status : Enrolling by invitation
First Posted : February 28, 2017
Last Update Posted : February 6, 2019
|Condition or disease|
|Coronary Artery Disease|
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 or without 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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||600 participants|
|Target Follow-Up Duration:||1 Year|
|Official Title:||The Prevalence and Influence of Obstructive Sleep Apnea in Coronary Artery Disease in Modern Age: Findings in A Large Cohort Study|
|Actual Study Start Date :||February 14, 2017|
|Estimated Primary Completion Date :||December 14, 2020|
|Estimated Study Completion Date :||December 14, 2020|
CAD with OSA
coronary artery disease with Obstructive sleep apnea
CAD without OSA
coronary artery disease without Obstructive sleep apnea
- Association of apnea-hypopnea index (AHI) between obstructive sleep apnea and severity of coronary artery disease [ Time Frame: 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.
- The Prevalence of Obstructive Sleep Apnea in Coronary Artery Disease in China [ Time Frame: 12 months ]The number of patients with Obstructive Sleep Apnea in Coronary Artery Disease in China
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03066141
|center of pulmonary vascular disease, Fuwai hospital|
|Beijing, China, 100037|
|Study Chair:||Zhihong Liu, M.D||Fuwai Hospital|