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

NCT03066141 | Completed DMC

• 1 other identifier: ChinesePVDRG
• Study Type: observational
• Target: 255
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The Prevalence of Obstructive Sleep Apnea in Coronary Artery Disease in China

  12 months

Study Arms (2)

CAD with OSA

coronary artery disease with Obstructive sleep apnea

CAD without OSA

coronary artery disease without Obstructive sleep apnea

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese Pulmonary Vascular Disease Research Group: lead

Study Sites (1)

center of pulmonary vascular disease, Fuwai hospital

Beijing, 100037, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Zhihong Liu, M.D

  Chinese Academy of Medical Sciences, Fuwai Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2017
• First Posted: February 28, 2017
• Study Start: February 14, 2017
• Primary Completion: August 29, 2019
• Study Completion: August 29, 2019
• Last Updated: September 17, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)