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Obstructive Sleep Apnea and Venous Thromboembolism (OSAVTE)

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ClinicalTrials.gov Identifier: NCT01051297
Recruitment Status : Terminated (Investigator left the institution)
First Posted : January 18, 2010
Last Update Posted : September 30, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Obstructive Sleep Apnea Venous Thrombosis Pulmonary Embolism Venous Thromboembolism

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
Actual Enrollment : 85 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Patients With Obstructive Sleep Apnea (OSA), Independent of Obesity, Are at Increased Risk of Venous Thromboembolic Events (VTE)
Study Start Date : March 2009
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

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



Primary Outcome Measures :
  1. incidence of VTE for the OSA cohort [ Time Frame: 12 months ]
  2. incidence of OSA for the VTE cohort [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. death [ Time Frame: 12 month ]
  2. bleeding [ Time Frame: 12 months ]
  3. composite outcome of death, VTE , or bleeding [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients (>=18 years) with sleep study , OSA or VTE
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Below 18 years of age

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01051297


Sponsors and Collaborators
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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT01051297     History of Changes
Other Study ID Numbers: 1132357
First Posted: January 18, 2010    Key Record Dates
Last Update Posted: September 30, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Missouri-Columbia:
Obstructive sleep apnea
venous thrombosis
pulmonary embolism
venous thromboembolism

Additional relevant MeSH terms:
Venous Thrombosis
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Thrombosis
Thromboembolism
Embolism
Venous Thromboembolism
Pulmonary Embolism
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases