Trial record 8 of 745 for:    "Venous Thromboembolism"

Obstructive Sleep Apnea and Venous Thromboembolism (OSAVTE)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT01051297
First received: January 15, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
  Purpose

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
Obstructive Sleep Apnea
Venous Thrombosis
Pulmonary Embolism
Venous Thromboembolism

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by University of Missouri-Columbia:

Primary Outcome Measures:
  • incidence of VTE for the OSA cohort [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • incidence of OSA for the VTE cohort [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • death [ Time Frame: 12 month ] [ Designated as safety issue: No ]
  • bleeding [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • composite outcome of death, VTE , or bleeding [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 185
Study Start Date: March 2009
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by University of Missouri-Columbia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: OUSAMA DABBAGH MD MSPH FCCP, UNIVERSITY OF MISSOURI
ClinicalTrials.gov Identifier: NCT01051297     History of Changes
Other Study ID Numbers: 1132357
Study First Received: January 15, 2010
Last Updated: January 15, 2010
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on July 22, 2014