Cardiovascular Diseases Clinical Trial
Official title:
Platelet Activation and Circadian Rhythms of Clotting-Fibrinolysis Factors in Patients With Sleep Apnea Syndrome. Implications in the Precipitation of Cardiovascular Events
The objective of the study is to define and compare clotting- fibrinolysis patterns, platelet function markers and endothelial dysfunction in patients with SAHS before and after treatment and normal controls age and weight matched.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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