Obstructive Sleep Apnea and Venous Thromboembolism

Obstructive Sleep Apnea Clinical Trial

— OSAVTE  

Official title:

Patients With Obstructive Sleep Apnea (OSA), Independent of Obesity, Are at Increased Risk of Venous Thromboembolic Events (VTE)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01051297
• Other study ID #: 1132357
• Status: Terminated
• Phase: N/A
• First received: January 15, 2010
• Last updated: September 29, 2016
• Start date: March 2009
• Est. completion date: May 2015

Study information

• Verified date: September 2016
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 85
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Below 18 years of age

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Apnea
• Embolism
• Obstructive Sleep Apnea
• Pulmonary Embolism
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Thromboembolism
• Thrombosis
• Venous Thromboembolism
• Venous Thrombosis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of VTE for the OSA cohort		12 months	No
Primary	incidence of OSA for the VTE cohort		12 months	No
Secondary	death		12 month	No
Secondary	bleeding		12 months	Yes
Secondary	composite outcome of death, VTE , or bleeding		12 months	No