Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00501358
Status:
UNKNOWN
Last Update Posted:
2007-07-16
First Post:
2007-07-13
Brief Title:
Sleep Apnea and Tromboembolic Disease
Sponsor:
Sociedad Española de Neumología y Cirugía Torácica
Organization:
Sociedad Española de Neumología y Cirugía Torácica
Study Overview
Official Title:
Assessment of Sleep Apnea Syndrome as a Risk Factor for Venous Thromboembolism
Status:
UNKNOWN
Status Verified Date:
2007-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
OBJECTIVESTo 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
OBJECTIVESTo 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None