NCT01051297

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.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2009

Longer than P75 for all trials

Status
terminated

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

March 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 18, 2010

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

September 30, 2016

Status Verified

September 1, 2016

Enrollment Period

6.2 years

First QC Date

January 15, 2010

Last Update Submit

September 29, 2016

Conditions

Obstructive Sleep ApneaVenous ThrombosisPulmonary EmbolismVenous Thromboembolism

Keywords

Obstructive sleep apneavenous thrombosispulmonary embolismvenous thromboembolism

Outcome Measures

Primary Outcomes (2)

  • incidence of VTE for the OSA cohort

    12 months

  • incidence of OSA for the VTE cohort

    12 months

Secondary Outcomes (3)

  • death

    12 month

  • bleeding

    12 months

  • composite outcome of death, VTE , or bleeding

    12 months

Study Arms (5)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Below 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Bosanquet JP, Bade BC, Zia MF, Karo A, Hassan O, Hess BT, Dabbagh O. Patients with venous thromboembolism appear to have higher prevalence of obstructive sleep apnea than the general population. Clin Appl Thromb Hemost. 2011 Nov-Dec;17(6):E119-24. doi: 10.1177/1076029610389023. Epub 2010 Dec 15.

    PMID: 21159707DERIVED

MeSH Terms

Conditions

Sleep Apnea, ObstructiveVenous ThrombosisPulmonary EmbolismVenous Thromboembolism

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesLung DiseasesEmbolismThromboembolism

Study Officials

  • OUSAMA DABBAGH, MD

    University of Missouri-Columbia

    PRINCIPAL INVESTIGATOR

  • JAMES P BOSANQUET, MD

    University of Missouri-Columbia

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 15, 2010

First Posted

January 18, 2010

Study Start

March 1, 2009

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

September 30, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share