Sleep Apnea and Tromboembolic Disease

NCT ID: NCT00501358

Last Updated: 2007-07-16

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Study Classification

OBSERVATIONAL

Brief Summary

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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

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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

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Sleep Apnea Syndromes Venous Thromboembolism

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundacion Caubet-Cimera Islas Baleares

OTHER

Sponsor Role collaborator

Sociedad Española de Neumología y Cirugía Torácica

OTHER

Sponsor Role lead

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

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Alberto Alonso, MD

Role: CONTACT

0034971175112

Other Identifiers

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TEP-SAHS

Identifier Type: -

Identifier Source: org_study_id