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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01051297
Other study ID # 1132357
Secondary ID
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


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
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