Sleep Apnea and Tromboembolic Disease
Recruitment status was Recruiting
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Purpose
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 |
|---|
|
Sleep Apnea Syndromes Venous Thromboembolism |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Primary Purpose: Screening Time Perspective: Cross-Sectional Time Perspective: Retrospective/Prospective |
| Official Title: | Assessment of Sleep Apnea Syndrome as a Risk Factor for Venous Thromboembolism |
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.
Eligibility| Genders Eligible for Study: | Both |
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
Contacts and Locations| Contact: Alberto Alonso, MD | 0034971175112 | aalonso@hsd.es |
| Spain | |
| Hospital Universitario Son Dureta | Recruiting |
| Palma de Mallorca, Baleares, Spain, 07014 | |
| Principal Investigator: | Alberto Alonso, MD | Sociedad Española de Neumología y Cirugía Torácica |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00501358 History of Changes |
| Other Study ID Numbers: | TEP-SAHS |
| Study First Received: | July 13, 2007 |
| Last Updated: | July 13, 2007 |
| Health Authority: | Spain: Ministry of Health and Consumption |
Keywords provided by Sociedad Española de Neumología y Cirugía Torácica:
|
SLEEP APNEA venous thromboembolism COAGULABILITY COAGULATION FACTORS HYPOXIA |
Additional relevant MeSH terms:
|
Apnea Sleep Apnea Syndromes Thromboembolism Venous Thromboembolism Venous Thrombosis Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms |
Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Thrombosis |
ClinicalTrials.gov processed this record on May 21, 2013