NCT00501358

Brief Summary

There is some evidence for a hypercoagulable state in sleep apnea-hipopnea syndrome (SAHS), which could play a role in the increased cardiovascular morbility and mortality. Respiratory alterations (hypoxia, hypoxia- reoxygenation) and sleep fragmentation that these patients suffer during the sleep may induce modifications in clotting-fibrinolisis factors that may be a risk factor for venous thromboembolism (VTE). OBJECTIVES:To calculate and compare the prevalence of sleep apnea-hipopnea syndrome in patients with venous thromboembolism with a gender, aged and BMI matched control group. Assessment of the association between SAHS and other risk factors for VTE. To compare clotting- fibrinolisis patterns, sleep parameters, blood pressure and pulmonary arterial obstruction index in patients with SAHS and VTE and those ones without SAHS.

Trial Health

55
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Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 16, 2007

Completed
Last Updated

July 16, 2007

Status Verified

July 1, 2007

First QC Date

July 13, 2007

Last Update Submit

July 13, 2007

Conditions

Sleep Apnea SyndromesVenous Thromboembolism

Keywords

SLEEP APNEAvenous thromboembolismCOAGULABILITYCOAGULATION FACTORSHYPOXIA

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Case group:
  • Pulmonary embolism diagnosed by CT Pulmonary Angiography.
  • Control group:
  • randomly selected from among patients in two primary health care centers in Mallorca without tromboembolic disease

You may not qualify if:

  • Refusal to sign informed consent.
  • Expected survival less than 12 months
  • Long-term oxygen therapy
  • Hospital admission in the previous two months.
  • Familiar thrombophilia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Son Dureta

Palma de Mallorca, Balearic Islands, 07014, Spain

RECRUITING

MeSH Terms

Conditions

Sleep Apnea SyndromesVenous ThromboembolismHypoxia

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Alberto Alonso, MD

    Sociedad Española de Neumología y Cirugía Torácica

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alberto Alonso, MD

CONTACT

0034971175112aalonso@hsd.es

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 13, 2007

First Posted

July 16, 2007

Last Updated

July 16, 2007

Record last verified: 2007-07

Locations

ES(1)