Clinical trial NCT03066141: Evaluation of Association Between Obstructive Sleep Apnea and the Severity of Coronary Artery Disease
Official title: The Prevalence and Influence of Obstructive Sleep Apnea in Coronary Artery Disease in Modern Age: Findings in A Large Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: Chinese Pulmonary Vascular Disease Research Group
Sponsor class: OTHER
First posted: 2017-02-28
Enrollment: 255
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Association of apnea-hypopnea index (AHI) between obstructive sleep apnea and severity of coronary artery disease
timeFrame: 12 months
Secondary outcomes:
measure: The Prevalence of Obstructive Sleep Apnea in Coronary Artery Disease in China
timeFrame: 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: center of pulmonary vascular disease, Fuwai hospital
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Zhihong Liu, M.D
role: STUDY_CHAIR
References: