跳至主要内容
临床试验/NCT03438149
NCT03438149招募中不适用

Microparticles as a Biomarker of Incident Cardiovascular Risk in Patients With Obstructive Sleep Apnea

University Hospital, Angers1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2018年2月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
300
试验地点
1
主要终点
myocardial infarction (acute infarct or silent myocardial infarction or unstable angina)

研究概览

简要总结

Obstructive sleep apnea (OSA) is independently associated with cardiovascular diseases, including myocardial infarction and stroke. OSA may promote atherosclerosis risk factors such as hypertension, diabetes and dyslipidemia and may have direct proatherogenic effects on the vascular wall. A growing number of studies have recently focused on the role of microparticles (MPs) in the atherogenic process. Case-control studies have shown that platelet-, endothelial- and leukocyte-derived MP levels are increased in OSA and that leukocyte-derived MP are released during the night in OSA. Furthermore, experimental evidence shows that MPs from OSA patients induce endothelial dysfunction.

The objective of this prospective study is to evaluate the impact of increased levels of leukocyte derived MPs on the cardiovascular outcomes in patients with prevalent cardiovascular diseases investigated for OSA.

详细描述

MPs are small plasma membrane vesicles that can be released by a variety of vascular or blood cells and that contain membrane and cytosolic elements. Case-control studies have shown that platelet-, endothelial- and leukocyte-derived MP levels are increased in OSA. Experimental evidence shows that MPs from OSA patients induce endothelial dysfunction, inflammation, and vascular hyperreactivity when injected to mice.

The impact of increased levels of MPs on the cardiovascular prognosis in OSA patient with prevalent cardiovascular diseases in unknown.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosis of coronary artery disease or cerebrovascular disease
  • diagnosis of moderate-to-severe OSA

排除标准

  • pregnancy
  • previously treated OSA

结局指标

主要结局

myocardial infarction (acute infarct or silent myocardial infarction or unstable angina)

时间窗: first event within 5 years after inclusion

outcomes assessed every year at the follow up visit or by calling the primary care physician

cerebrovascular infarction (stroke or transient ischemic attack)

时间窗: first event within 5 years after inclusion

outcomes assessed every year at the follow up visit or by calling the primary care physician

death from any cardiovascular cause

时间窗: first event within 5 years after inclusion

outcomes assessed every year at the follow up visit or by calling the primary care physician

hospitalization for heart failure

时间窗: first event within 5 years after inclusion

outcomes assessed every year at the follow up visit or by calling the primary care physician

次要结局

未报告次要终点

研究者

发起方
University Hospital, Angers
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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