Obstructive Sleep Apnea and Venous Thromboembolism

Terminated

• Conditions: Pulmonary Embolism; Obstructive Sleep Apnea; Venous Thrombosis; Venous Thromboembolism

• Registration Number: NCT01051297
• Lead Sponsor: University of Missouri-Columbia

Brief Summary

There is a clear link between obstructive sleep apnea (OSA) and cardiovascular disease. However, there has been no clear link between OSA and venous thromboembolism (VTE). The objective of this study is to evaluate such a link.

Detailed Description

Design:

1. retrospective chart review of all patients with VTE over 10 year period

2. retrospective chart review of all patients with OSA over 10 year period

3. prospective 1 year follow up of all patients diagnosed with new VTE

4. prospective 1 year follow up of all patients undergoing sleep study

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2010-01-15
• Study First Submitted QC: 2010-01-15
• Study First Posted: 2010-01-18
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-29
• Last Update Posted: 2016-09-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

• Adult patients (>= 18 years) with sleep study, OSA or VTE

Exclusion Criteria

• Below 18 years of age

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
incidence of OSA for the VTE cohort	12 months
incidence of VTE for the OSA cohort	12 months

Secondary Outcome Measures

Name	Time	Method
composite outcome of death, VTE , or bleeding	12 months
death	12 month
bleeding	12 months