Ignite Creation Date:
2024-05-06 @ 9:45 AM
Last Modification Date:
2024-10-26 @ 12:19 PM
Study NCT ID:
NCT03066141
Status:
COMPLETED
Last Update Posted:
2019-09-17
First Post:
2017-02-19
Brief Title:
Evaluation of Association Between Obstructive Sleep Apnea and the Severity of Coronary Artery Disease
Sponsor:
Chinese Pulmonary Vascular Disease Research Group
Organization:
Chinese Pulmonary Vascular Disease Research Group
Study Overview
Official Title:
The Prevalence and Influence of Obstructive Sleep Apnea in Coronary Artery Disease in Modern Age Findings in A Large Cohort Study
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 213 million cardiovascular events and 77 million cardiovascular deaths over 2010 to 2030 in China1 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 kgm2 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None