Venous Thromboembolism Clinical Trial
Official title:
Assessment of Sleep Apnea Syndrome as a Risk Factor for Venous Thromboembolism
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.
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.
;
Observational Model: Case Control, Primary Purpose: Screening, Time Perspective: Cross-Sectional
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