Sleep Apnea and Tromboembolic Disease

Venous Thromboembolism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00501358
• Other study ID #: TEP-SAHS
• Status: Recruiting
• Phase: N/A
• First received: July 13, 2007
• Last updated: July 13, 2007

Study information

• Verified date: July 2007
• Source: Sociedad Española de Neumología y Cirugía Torácica
• Contact: Alberto Alonso, MD
• Phone: 0034971175112
• Email: aalonso[@]hsd.es
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health and Consumption
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Case Control, Primary Purpose: Screening, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes
• Thromboembolism
• Venous Thromboembolism

Locations

Country	Name	City	State
Spain	Hospital Universitario Son Dureta	Palma de Mallorca	Baleares

Sponsors (2)

Lead Sponsor	Collaborator
Sociedad Española de Neumología y Cirugía Torácica	Fundacion Caubet-Cimera Islas Baleares

Country where clinical trial is conducted

Spain,