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临床试验/NCT07728656
NCT07728656招募中不适用

Endothelial Extracellular Vesicles as Biomarkers of Blood Pressure-Induced Endothelial Activation in Pregnant Women With Hypertensive Disorders of Pregnancy

Josip Juraj Strossmayer University of Osijek1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
1
主要终点
Plasma endothelial extracellular vesicle concentration

研究概览

简要总结

Hypertensive disorders of pregnancy are associated with endothelial dysfunction and increased maternal and fetal morbidity. Endothelial extracellular vesicles (EEVs) have emerged as promising biomarkers of endothelial activation; however, their relationship with blood pressure and endothelial function during pregnancy remains incompletely understood. This observational case-control study aims to compare circulating EEV concentrations between normotensive pregnant women and pregnant women with hypertensive disorders of pregnancy. The study will also investigate the associations between EEV levels, blood pressure, microvascular endothelial function assessed by laser Doppler flowmetry, and circulating biomarkers of endothelial activation. The findings may improve understanding of endothelial injury during pregnancy and support the development of non-invasive biomarkers for early detection and monitoring of hypertensive disorders of pregnancy.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

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

入选标准

  • Pregnant women aged ≥18 years.
  • Singleton pregnancy.
  • Ability to provide written informed consent.
  • Normotensive pregnancy or diagnosis of gestational hypertension or preeclampsia according to current clinical guidelines.
  • Ability to comply with study procedures.

排除标准

  • Chronic hypertension diagnosed before pregnancy.
  • Multiple pregnancy.
  • Pre-existing diabetes mellitus.
  • Chronic kidney disease.
  • Autoimmune disease.
  • Known cardiovascular disease.
  • Active infection or inflammatory disease.
  • Malignancy.
  • Inability or unwillingness to provide informed consent.

结局指标

主要结局

Plasma endothelial extracellular vesicle concentration

时间窗: Baseline

Concentration of circulating endothelial extracellular vesicles quantified by flow cytometry following size-exclusion chromatography isolation.

次要结局

  • Post-occlusive reactive hyperemia (PORH)(Baseline)
  • Acetylcholine-induced vasodilation (AChID)(Baseline)
  • Sodium nitroprusside-induced vasodilation (SNPID)(Baseline)
  • VCAM-1 concentration(Baseline)
  • ICAM-1 concentration(Baseline)
  • Endocan concentration(Baseline)
  • von Willebrand factor (vWF)(Baseline)
  • Matrix metalloproteinase-9 (MMP-9)(Baseline)

研究者

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

Ines Drenjancevic

Full Proffesor Tenure, Head of Department of Physiology and Immunology, Faculty of Medicine Osijek

Josip Juraj Strossmayer University of Osijek

研究点 (1)

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