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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

center of pulmonary vascular disease, Fuwai hospital

Beijing, 100037, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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.

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Chinese Pulmonary Vascular Disease Research Group

Other

Registry information

Official study title

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

Important dates

Study start: 2017
Primary completion: 2019
Study completion: 2019
First posted: Feb 5, 2021
Registry last updated: Feb 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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