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

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

Study Overview

• Status: Unknown
• Conditions: Sleep Apnea, Obstructive; AAA - Abdominal Aortic Aneurysm

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 1800

Contacts and Locations

Study Locations

• China
  • Beijing, China, 102218
    • Beijing Tsinghua Changgung Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who are diagnosis as OSAHS

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diameter of aorta	Diameter of aorta measured by ultrasound	0-48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ABI	Ankel brachal index measured by Angiolab 2 - Phlebolab Doppler-System	0-48 hours
Carotid artery stenosis	Carotid artery stenosis measured by ultrasound	0-48 hours

Collaborators and Investigators

• Sponsor: Beijing Tsinghua Chang Gung Hospital
• Investigators: Principal Investigator: Weiwei Wu, MD, Beijing Tsinghua Changgeng Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Anticipated): November 30, 2019
• Study Completion (Anticipated): June 1, 2020

Study Registration Dates

• First Submitted: February 7, 2018
• First Submitted That Met QC Criteria: February 7, 2018
• First Posted (Actual): February 13, 2018

Study Record Updates

• Last Update Posted (Actual): February 23, 2018
• Last Update Submitted That Met QC Criteria: February 21, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Aortic Diseases; Sleep Apnea, Obstructive; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: 17084-0310

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No