Trials / Unknown
UnknownNCT00501358
Sleep Apnea and Tromboembolic Disease
Assessment of Sleep Apnea Syndrome as a Risk Factor for Venous Thromboembolism
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- —
- Sponsor
- Sociedad Española de Neumología y Cirugía Torácica · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- —
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.
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.
Conditions
Timeline
- First posted
- 2007-07-16
- Last updated
- 2007-07-16
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT00501358. Inclusion in this directory is not an endorsement.