Platelet Activation and Circadian Rhythms of Clotting-Fibrinolysis Factors in Patients With Sleep Apnea Syndrome
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|ClinicalTrials.gov Identifier: NCT00456287|
Recruitment Status : Unknown
Verified April 2007 by Sociedad Española de Neumología y Cirugía Torácica.
Recruitment status was: Recruiting
First Posted : April 4, 2007
Last Update Posted : April 4, 2007
|Condition or disease||Intervention/treatment|
|Sleep Apnea Cardiovascular Diseases||Device: CPAP (Continuous Positive Airway Pressure)|
The hypothesis of the study is the following: Patients with sleep apnea-hypopnea syndrome have higher risk of cardiovascular mortality during the night.
Respiratory alterations (hypoxia, hypoxia- reoxygenation) that these patients suffer during the sleep may induce modifications in platelet function, clotting-fibrinolysis factors and endothelial function, that may accelerate cardiovascular events during the night
DESIGN: Prospective and controlled study
METHODS: 20 SAHS patients and 20 controls will be studied. The study includes:
a) medical history; b) anthropometric variables (weight, height, body mass index, waist-hip ratio); c) sleepiness tested by Epworth scale; d) conventional polysomnography (PSG); e) testing every 4 hours for a 24 hours period: clotting-fibrinolysis factors (factor V, VII, VIII; C and S protein, plasminogen tissular activator (t-PA) and inhibitor of plasminogen activator (PAI-1); platelet activation markers (CD62, CD63 and GPIIb/IIIa) and endothelial dysfunction markers (endothelins, nitrites/nitrates and asymmetrical dimethyl-arginine); f) basic biochemical profile and hemogram. Patients will be revaluated after 6 months of CPAP treatment.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Platelet Activation and Circadian Rhythms of Clotting-Fibrinolysis Factors in Patients With Sleep Apnea Syndrome. Implications in the Precipitation of Cardiovascular Events|
|Study Start Date :||February 2007|
- To define and compare clotting- fibrinolysis patterns, platelet function markers and endothelial dysfunction
- CPAP (Continuous Positive Airway Pressure) effect on studied variables
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): NCT00456287
|Contact: Antonia Barceló, MD||34 971 firstname.lastname@example.org|
|Hospital Universitario Son Dureta||Recruiting|
|Palma de Mallorca, Baleares, Spain, 07014|
|Principal Investigator:||Antonia Barceló, MD||Hospital Universitario Son Dureta|