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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03431038
Other study ID # 17084-0310
Secondary ID
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
Health authority
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.

Study Design


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
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