NCT03431038

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 13, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

February 23, 2018

Status Verified

February 1, 2018

Enrollment Period

2.2 years

First QC Date

February 7, 2018

Last Update Submit

February 21, 2018

Conditions

Sleep Apnea, ObstructiveAAA - Abdominal Aortic Aneurysm

Outcome Measures

Primary Outcomes (1)

  • Diameter of aorta

    Diameter of aorta measured by ultrasound

    0-48 hours

Secondary Outcomes (2)

  • ABI

    0-48 hours

  • Carotid artery stenosis

    0-48 hours

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who are diagnosis as OSAHS

You may qualify if:

  • 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

You may not qualify if:

  • \. Any previous diagnosis of AAA history;
  • \. Received AAA related treatment;
  • \. Past imaging test result suggested increased diameter of the abdominal aorta.
  • \. Poor compliance; refused to follow the requirements set in this study follow-up, and refused to sign informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tsinghua Changgung Hospital

Beijing, 102218, China

Location

MeSH Terms

Conditions

Sleep Apnea, ObstructiveAortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesAortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Officials

  • Weiwei Wu, MD

    Beijing Tsinghua Changgeng Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2018

First Posted

February 13, 2018

Study Start

September 1, 2017

Primary Completion

November 30, 2019

Study Completion

June 1, 2020

Last Updated

February 23, 2018

Record last verified: 2018-02

Locations

CN(1)