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Sleep Apnea and Tromboembolic Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00501358
Recruitment Status : Unknown
Verified July 2007 by Sociedad Española de Neumología y Cirugía Torácica.
Recruitment status was:  Recruiting
First Posted : July 16, 2007
Last Update Posted : July 16, 2007
Fundacion Caubet-Cimera Islas Baleares
Information provided by:
Sociedad Española de Neumología y Cirugía Torácica

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.

Condition or disease
Sleep Apnea Syndromes Venous Thromboembolism

Detailed Description:

DESIGN: Case-control study.

METHODS: 133 SAHS patients and 133 controls will be studied. The study includes:

a) medical history; b) anthropometric variables (weight, height, body mass index, Mallampati index); c) sleepiness tested by Epworth scale; d) London Chest Activity of Daily Living Scale; e) conventional polysomnography (PSG); f) testing: clotting-fibrinolisis factors (factor V, VII, VIII; C and S protein, plasminogen tissular activator (t-PA) and inhibitor of plasminogen activator (PAI-1); g) d-dimer and thrombin-antithrombin III complex; h) basic biochemical profile and hemograma; i) Pulmonary artery obstruction index.

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Study Type : Observational
Observational Model: Case-Control
Time Perspective: Other
Official Title: Assessment of Sleep Apnea Syndrome as a Risk Factor for Venous Thromboembolism

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

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 identifier (NCT number): NCT00501358

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Contact: Alberto Alonso, MD 0034971175112

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Hospital Universitario Son Dureta Recruiting
Palma de Mallorca, Baleares, Spain, 07014
Sponsors and Collaborators
Sociedad Española de Neumología y Cirugía Torácica
Fundacion Caubet-Cimera Islas Baleares
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Principal Investigator: Alberto Alonso, MD Sociedad Española de Neumología y Cirugía Torácica
Layout table for additonal information Identifier: NCT00501358    
Other Study ID Numbers: TEP-SAHS
First Posted: July 16, 2007    Key Record Dates
Last Update Posted: July 16, 2007
Last Verified: July 2007
Keywords provided by Sociedad Española de Neumología y Cirugía Torácica:
venous thromboembolism
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Venous Thromboembolism
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases