Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
OBSERVATIONAL
Brief Summary
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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
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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
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Study Design
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CASE_CONTROL
OTHER
Eligibility Criteria
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Inclusion Criteria
* 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
* Expected survival less than 12 months
* Long-term oxygen therapy
* Hospital admission in the previous two months.
* Familiar thrombophilia
ALL
No
Sponsors
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Fundacion Caubet-Cimera Islas Baleares
OTHER
Sociedad Española de Neumología y Cirugía Torácica
OTHER
Principal Investigators
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Alberto Alonso, MD
Role: PRINCIPAL_INVESTIGATOR
Sociedad Española de Neumología y Cirugía Torácica
Locations
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Hospital Universitario Son Dureta
Palma de Mallorca, Balearic Islands, Spain
Countries
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Central Contacts
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Other Identifiers
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TEP-SAHS
Identifier Type: -
Identifier Source: org_study_id