Sleep Apnea and Tromboembolic Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by Sociedad Española de Neumología y Cirugía Torácica.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Fundacion Caubet-Cimera Islas Baleares
Information provided by:
Sociedad Española de Neumología y Cirugía Torácica
ClinicalTrials.gov Identifier:
NCT00501358
First received: July 13, 2007
Last updated: NA
Last verified: July 2007
History: No changes posted
  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
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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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:
Sleep Apnea Syndromes
Apnea
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 July 23, 2014