Cross-sectional Study of Prevalence Rate of Abdominal Aortic Aneurysm in OSAHS Patients From BTCH

Sleep Apnea, Obstructive Clinical Trial

Official title:

Cross-sectional Study of Prevalence Rate of Abdominal Aortic Aneurysm in OSAHS Patients From BTCH

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03431038
• Other study ID #: 17084-0310
• Status: Active, not recruiting
• Phase: N/A
• First received: February 7, 2018
• Last updated: February 21, 2018
• Start date: September 1, 2017
• Est. completion date: June 1, 2020

Study information

• Verified date: February 2018
• Source: Beijing Tsinghua Chang Gung Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study explore AAA prevalence in OSAHS patients by ultrasound screening and try to analysis risk factors of AAA in OSAHS patients.

Description:

Abdominal aortic aneurysm (AAA) is an extremely high mortality disease, and ultrasound has been recommended for the screening of AAA, which is highly sensitive and specific. Studies have shown that screening for AAA in the population can significantly reduce deaths from ruptured abdominal aortic aneurysms. However, those study mainly focus on cardiovascular disease patients or general population, no previous study target on obstructive sleep apnea hypopnea syndrome (OSAHS) population. Retrospective studies show that the incidence of apnea syndrome in patients with abdominal aortic aneurysm is higher than that in the control group, which suggests that OSAHS may be one of the causes of abdominal aortic aneurysm. At present, there is no relevant research on the screening of AAA in OSAHS population.

The main objective of this study was to screen the prevalence of AAA in OSAHS population by a cross-sectional study.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1800
• Est. completion date: June 1, 2020
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• All patients who accept respiratory sleep monitoring in the department of ENT, BTCH, aged over 45 years, from 2018-01-01 to 2019-12-30

Exclusion Criteria:

• 1. Any previous diagnosis of AAA history;

• 2. Received AAA related treatment;

• 3. Past imaging test result suggested increased diameter of the abdominal aorta.

• 4. Poor compliance; refused to follow the requirements set in this study follow-up, and refused to sign informed consent.

Related Conditions & MeSH terms

• AAA - Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
China	Beijing Tsinghua Changgung Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tsinghua Chang Gung Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diameter of aorta	Diameter of aorta measured by ultrasound	0-48 hours
Secondary	ABI	Ankel brachal index measured by Angiolab 2 - Phlebolab Doppler-System	0-48 hours
Secondary	Carotid artery stenosis	Carotid artery stenosis measured by ultrasound	0-48 hours