Assessment of Sleep Apnea Syndrome as a Risk Factor for Venous Thromboembolism
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Locations
- 1
Study Overview
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.
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Other
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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