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临床试验/NCT04327492
NCT04327492Unknown不适用

Clinical, Hematological, and Imagiologic Predictors of Postoperative Complications and Long Term Cardiovascular Events After Carotid Endarterectomy With Regional Anesthesia

Universidade do Porto1 个研究点 分布在 1 个国家目标入组 272 人开始时间: 2020年4月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
272
试验地点
1
主要终点
Stroke

研究概览

简要总结

Establish and validate biomarkers which improve the predictive value of current risk stratification models for patients benefiting from carotid revascularization, outperform existing biomarkers, and reach clinical application standards.

详细描述

The authors hypothesize FGF-23 and GDF-15 could predict cerebral ischemia, postoperative complications and long term major cardiovascular events, particularly in patients developing symptomatic neurologic ischemia after circulation shutdown.

Establish and validate biomarkers which improve the predictive value of current risk stratification models for patients benefiting from carotid revascularization, outperform existing biomarkers, and reach clinical application standards.

Clarify the pathophysiology of carotid endarterectomy-related stroke and the role of GDF-15, FGF-23, BNP and hs-troponin I and other biomarkers in the prognosis of symptomatic carotid stenosis.

Imagiologic markers are to be included - intima-media; gray weale plaque classification, cerebral CT Peak wave velocity

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • consecutive patients from a tertiary referral center who undergo CEA for carotid artery stenosis (CS) under regional anesthesia

排除标准

  • general anesthesia
  • carotid stenting

结局指标

主要结局

Stroke

时间窗: 30 days, long-term

Clavien dindo>3

时间窗: 30 days, long-term

MACE

时间窗: 30 days, long-term

AMI, stroke, Major adverse limb event, acute hear faillure hospitalization, all cause mortality

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

João Rocha Neves

MD, MSC; MPH, FEBVS

Universidade do Porto

研究点 (1)

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