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Sleep Apnea and Tromboembolic Disease

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00501358
Enrollment
Unknown
Registered
2007-07-16
Start date
Unknown
Completion date
Unknown
Last updated
2007-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Apnea Syndromes, Venous Thromboembolism

Keywords

SLEEP APNEA, venous thromboembolism, COAGULABILITY, COAGULATION FACTORS, HYPOXIA

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.

Interventions

None listed

Sponsors

Fundacion Caubet-Cimera Islas Baleares
CollaboratorOTHER
Sociedad Española de Neumología y Cirugía Torácica
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
OTHER

Eligibility

Sex/Gender
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

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

Countries

Spain

Contacts

Primary ContactAlberto Alonso, MD
aalonso@hsd.es0034971175112

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026