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临床试验/NCT00456287
NCT00456287Unknown不适用

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

Sociedad Española de Neumología y Cirugía Torácica1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2007年2月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
1
主要终点
To define and compare clotting- fibrinolysis patterns, platelet function markers and endothelial dysfunction

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
25 Years 至 65 Years(Adult, Older Adult)
性别
Male
接受健康志愿者
否

入选标准

  • •Apnea-Hypopnea Index > 15

排除标准

  • •Presence of any chronic disease
  • •Presence of cardiovascular disease
  • •Refusal to sign informed consent
  • •Drug addiction and/or alcoholism
  • •Any medication two weeks before

结局指标

主要结局

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

次要结局

  • CPAP (Continuous Positive Airway Pressure) effect on studied variables

研究者

发起方
Sociedad Española de Neumología y Cirugía Torácica
申办方类型
Other

研究点 (1)

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