Obstructive Sleep Apnea and Venous Thromboembolism (OSAVTE)

September 29, 2016 updated by: University of Missouri-Columbia

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

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.

Study Overview

Status

Terminated

Conditions

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 Type

Observational

Enrollment (Actual)

85

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Below 18 years of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
VTE -PROSPECTIVE
Patients diagnosed with VTE
sleep study group -PROSPECTIVE
patients undergoing sleep study
VTE-Retrospective
patients with VTE , chart review
OSA-retrospective
PATIENT WITH OSA -CHART REVIEW
OSA group -PROSPECTIVE
patients diagnosed with OSA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
incidence of VTE for the OSA cohort
Time Frame: 12 months
12 months
incidence of OSA for the VTE cohort
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
death
Time Frame: 12 month
12 month
bleeding
Time Frame: 12 months
12 months
composite outcome of death, VTE , or bleeding
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Missouri-Columbia

Investigators

  • Principal Investigator: OUSAMA DABBAGH, MD, University of Missouri-Columbia
  • Principal Investigator: JAMES P BOSANQUET, MD, University of Missouri-Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

January 15, 2010

First Submitted That Met QC Criteria

January 15, 2010

First Posted (Estimate)

January 18, 2010

Study Record Updates

Last Update Posted (Estimate)

September 30, 2016

Last Update Submitted That Met QC Criteria

September 29, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1132357

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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