Sleep Apnea and Tromboembolic Disease
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|ClinicalTrials.gov 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
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|
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.
|Study Type :||Observational|
|Observational Model:||Case Control|
|Official Title:||Assessment of Sleep Apnea Syndrome as a Risk Factor for Venous Thromboembolism|
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): NCT00501358
|Contact: Alberto Alonso, MDfirstname.lastname@example.org|
|Hospital Universitario Son Dureta||Recruiting|
|Palma de Mallorca, Baleares, Spain, 07014|
|Principal Investigator:||Alberto Alonso, MD||Sociedad Española de Neumología y Cirugía Torácica|