Evaluation of Association Between Obstructive Sleep Apnea and the Severity of Coronary Artery Disease

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03066141
• Other study ID #: ChinesePVDRG
• Status: Completed
• Start date: February 14, 2017
• Est. completion date: August 29, 2019

Study information

• Verified date: September 2019
• Source: Chinese Pulmonary Vascular Disease Research Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 255
• Est. completion date: August 29, 2019
• Est. primary completion date: August 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
China	center of pulmonary vascular disease, Fuwai hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Pulmonary Vascular Disease Research Group

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association of apnea-hypopnea index (AHI) between obstructive sleep apnea and severity of coronary artery disease	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
Secondary	The Prevalence of Obstructive Sleep Apnea in Coronary Artery Disease in China	The number of patients with Obstructive Sleep Apnea in Coronary Artery Disease in China	12 months