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临床试验/NCT02795377
NCT02795377已完成不适用

Hypertension, Endothelial Microparticle Release, and Endothelial Function: Role of Pressure, Shear, and Stretch

Klinik für Kardiologie, Pneumologie und Angiologie1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2016年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
Changes in endothelial function

研究概览

简要总结

Membrane microparticles are submicron fragments of membrane vesicles shed from various cell types. Circulating endothelial microparticles have been proposed as markers of endothelial injury. However, which mechanical forces contribute to their release is not clear.

详细描述

In a first series subjects (50% hypertensives) with and without arterial hypertension and no Coronary Artery Disease (CAD) (n=50) will be recruited. MP subpopulations will be discriminated by flow cytometry according to the expression of established surface antigens including CD31+/41-, CD144+, and CD62e+. Besides office and ambulatory 24h blood pressure measurements, pulse wave analysis will be performed to determine central blood pressure, augmentation index (AIX), and pulse wave velocity. Endothelial function (Flow-mediated dilation, FMD), arterial pulsatile stretch (fractional diameter changes, FDC), and wall-shear-stress (WSS) will be measured in the same segment of the brachial artery (BA) by ultrasound. In a second series, the investigators will take measurements in subjects with hypertensive crises (SBP>180 mmHg) (n=20) before and after 4h and normalization of arterial BP by urapidil. In a third series, the investigators will take measurement in subjects with stable CAD (n=10) before and after transfemoral coronary diagnostic angiography.

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
50 Years 至 80 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • male subjects with or without arterial hypertension, hypertensive crises, stable CAD
  • written informed consent

排除标准

  • subjects with manifest peripheral artery, or cerebrovascular disease, acute inflammation (CRP>0.6 mg/dl), malignancies, arrhythmias

结局指标

主要结局

Changes in endothelial function

时间窗: Baseline and 4 hours after procedure

endothelial function measured by flow-mediated dilation (FMD) for Subgroup 4 before and after transfemoral coronary diagnostic angiography

endothelial function

时间窗: Baseline

endothelial function measured by flow-mediated dilation (FMD) for Subgroup 1 and 2

次要结局

  • Microparticle(Baseline)
  • Changes in Microparticle(Baseline and after 4 hours)
  • Changes Microparticle(Baseline and 4 hours after procedure)
  • Wall Shear Stress(Baseline)
  • Changes in Wall Shear Stress(Baseline and 4 hours after procedure)
  • changes in fractional diameter (FDC)(Baseline and after 4 hours)
  • Changes in fractional diameter (FDC)(Baseline and 4 hours after procedure)
  • pulse wave velocity(Baseline)
  • Changes in pulse wave velocity(Baseline and 4 hours after procedure)
  • augmentation index(baseline)
  • Changes in augmentation index(Baseline and 4 hours after procedure)

研究者

发起方
Klinik für Kardiologie, Pneumologie und Angiologie
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Klinik für Kardiologie, Pneumologie und Angiologie

Principal Investigaor

Heinrich-Heine University, Duesseldorf

研究点 (1)

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