Platelet Activation and Circadian Rhythms of Clotting-Fibrinolysis Factors in Patients With Sleep Apnea Syndrome. Implications in the Precipitation of Cardiovascular Events
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- To define and compare clotting- fibrinolysis patterns, platelet function markers and endothelial dysfunction
Study Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 25 Years to 65 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Apnea-Hypopnea Index > 15
Exclusion Criteria
- •Presence of any chronic disease
- •Presence of cardiovascular disease
- •Refusal to sign informed consent
- •Drug addiction and/or alcoholism
- •Any medication two weeks before
Outcomes
Primary Outcomes
To define and compare clotting- fibrinolysis patterns, platelet function markers and endothelial dysfunction
Secondary Outcomes
- CPAP (Continuous Positive Airway Pressure) effect on studied variables