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Platelet Activation and Circadian Rhythms of Clotting-Fibrinolysis Factors in Patients With Sleep Apnea Syndrome

Platelet Activation and Circadian Rhythms of Clotting-Fibrinolysis Factors in Patients With Sleep Apnea Syndrome. Implications in the Precipitation of Cardiovascular Events

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00456287
Enrollment
40
Registered
2007-04-04
Start date
2007-02-28
Completion date
Unknown
Last updated
2007-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Sleep Apnea

Keywords

Sleep Apnea, Clotting- fibrinolysis patterns, Platelet function markers, Endothelial dysfunction

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.

Interventions

Sponsors

Fondo de Investigacion Sanitaria
CollaboratorOTHER
Fundacion Caubet-Cimera Islas Baleares
CollaboratorOTHER
Sociedad Española de Neumología y Cirugía Torácica
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
25 Years to 65 Years
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

Design outcomes

Primary

MeasureTime frame
To define and compare clotting- fibrinolysis patterns, platelet function markers and endothelial dysfunction

Secondary

MeasureTime frame
CPAP (Continuous Positive Airway Pressure) effect on studied variables

Countries

Spain

Contacts

Primary ContactAntonia Barceló, MD
abarcelo@hsd.es34 971 175112

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026