Sleep Apnea and Tromboembolic Disease
|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|
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|