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Sleep Apnea and Tromboembolic Disease

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2007 by Sociedad Española de Neumología y Cirugía Torácica.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00501358
First Posted: July 16, 2007
Last Update Posted: July 16, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Fundacion Caubet-Cimera Islas Baleares
Information provided by:
Sociedad Española de Neumología y Cirugía Torácica
  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

Resource links provided by NLM:


Further study details as provided by Sociedad Española de Neumología y Cirugía Torácica:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00501358


Contacts
Contact: Alberto Alonso, MD 0034971175112 aalonso@hsd.es

Locations
Spain
Hospital Universitario Son Dureta Recruiting
Palma de Mallorca, Baleares, Spain, 07014
Sponsors and Collaborators
Sociedad Española de Neumología y Cirugía Torácica
Fundacion Caubet-Cimera Islas Baleares
Investigators
Principal Investigator: Alberto Alonso, MD Sociedad Española de Neumología y Cirugía Torácica
  More Information

ClinicalTrials.gov Identifier: NCT00501358     History of Changes
Other Study ID Numbers: TEP-SAHS
First Submitted: July 13, 2007
First Posted: July 16, 2007
Last Update Posted: July 16, 2007
Last Verified: July 2007

Keywords provided by Sociedad Española de Neumología y Cirugía Torácica:
SLEEP APNEA
venous thromboembolism
COAGULABILITY
COAGULATION FACTORS
HYPOXIA

Additional relevant MeSH terms:
Syndrome
Apnea
Sleep Apnea Syndromes
Thromboembolism
Venous Thromboembolism
Disease
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases