Sleep Apnea and Tromboembolic Disease

Sponsor

Sociedad Española de Neumología y Cirugía Torácica (Other)

Overall Status

Unknown status

CT.gov ID

NCT00501358

Collaborator

Fundacion Caubet-Cimera Islas Baleares (Other)

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Apnea Syndromes Venous Thromboembolism

Detailed Description

DESIGN: Case-control study.

METHODS: 133 SAHS patients and 133 controls will be studied. The study includes:

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

Official Title:

Assessment of Sleep Apnea Syndrome as a Risk Factor for Venous Thromboembolism

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

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