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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00456287
• Other study ID #: PR-109
• Status: Recruiting
• Phase: N/A
• First received: April 2, 2007
• Last updated: April 2, 2007
• Start date: February 2007

Study information

• Verified date: April 2007
• Source: Sociedad Española de Neumología y Cirugía Torácica
• Contact: Antonia Barceló, MD
• Phone: 34 971 175112
• Email: abarcelo[@]hsd.es
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health and Consumption
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 25 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Apnea
• Cardiovascular Diseases
• Sleep Apnea
• Sleep Apnea Syndromes

Intervention

Device:
• CPAP (Continuous Positive Airway Pressure)

Locations

Country	Name	City	State
Spain	Hospital Universitario Son Dureta	Palma de Mallorca	Baleares

Sponsors (3)

Lead Sponsor	Collaborator
Sociedad Española de Neumología y Cirugía Torácica	Fondo de Investigacion Sanitaria, Fundacion Caubet-Cimera Islas Baleares

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To define and compare clotting- fibrinolysis patterns, platelet function markers and endothelial dysfunction
Secondary	CPAP (Continuous Positive Airway Pressure) effect on studied variables