Endothelial Extracellular Vesicles as Biomarkers of Endothelial Activation in Pregnant Women With Hypertensive Disorders of Pregnancy (HYPER-endoEV-p)
2026年7月22日 更新者：Ines Drenjancevic、Josip Juraj Strossmayer University of Osijek
Endothelial Extracellular Vesicles as Biomarkers of Blood Pressure-Induced Endothelial Activation in Pregnant Women With Hypertensive Disorders of Pregnancy
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.
研究概览
研究类型
观察性的
注册 (估计的)
80
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Martina Vulin, MD, PhD
- 电话号码：+38531512302
- 邮箱：martina.vulin@mefos.hr
研究联系人备份
- 姓名：Ana Stupin, MD, PhD
- 电话号码：+38531512800
- 邮箱：ana.stupin@mefos.hr
学习地点
-
-
-
Osijek、克罗地亚
- 招聘中
- Faculty of Medicine Osijek
-
接触：
- Ana Stupin, MD, PhD
- 电话号码：+38531512800
- 邮箱：medicina@mefos.hr
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
The study population will include pregnant women aged 18 years and older recruited from the outpatient clinics of the Department of Obstetrics and Gynecology, University Hospital Centre Osijek, Croatia.
Participants will comprise normotensive pregnant women and women with newly diagnosed hypertensive disorders of pregnancy, including gestational hypertension and preeclampsia, diagnosed according to current international clinical guidelines.
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
|---|
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Normotensive Pregnancy
Pregnant women with normal blood pressure and uncomplicated singleton pregnancy.
|
|
Hypertensive Disorders of Pregnancy
Pregnant women diagnosed with hypertensive disorders of pregnancy, including gestational hypertension or preeclampsia, according to current clinical guidelines.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Plasma endothelial extracellular vesicle concentration
大体时间：Baseline
|
Concentration of circulating endothelial extracellular vesicles quantified by flow cytometry following size-exclusion chromatography isolation.
|
Baseline
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Post-occlusive reactive hyperemia (PORH)
大体时间：Baseline
|
Microvascular endothelium-dependent vasodilation assessed by laser Doppler flowmetry following 1-minute arterial occlusion.
|
Baseline
|
|
Acetylcholine-induced vasodilation (AChID)
大体时间：Baseline
|
Endothelium-dependent microvascular vasodilation assessed by acetylcholine iontophoresis and laser Doppler flowmetry.
|
Baseline
|
|
Sodium nitroprusside-induced vasodilation (SNPID)
大体时间：Baseline
|
Endothelium-independent microvascular vasodilation assessed by sodium nitroprusside iontophoresis and laser Doppler flowmetry.
|
Baseline
|
|
VCAM-1 concentration
大体时间：Baseline
|
Plasma vascular cell adhesion molecule-1 (VCAM-1) concentration measured as a marker of endothelial activation.
|
Baseline
|
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ICAM-1 concentration
大体时间：Baseline
|
Plasma intercellular adhesion molecule-1 (ICAM-1) concentration measured as a marker of endothelial activation.
|
Baseline
|
|
Endocan concentration
大体时间：Baseline
|
Plasma endocan concentration measured as a marker of endothelial dysfunction.
|
Baseline
|
|
von Willebrand factor (vWF)
大体时间：Baseline
|
Plasma von Willebrand factor concentration measured as a marker of endothelial injury.
|
Baseline
|
|
Matrix metalloproteinase-9 (MMP-9)
大体时间：Baseline
|
Plasma MMP-9 concentration measured as a marker of vascular remodeling and endothelial dysfunction.
|
Baseline
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Ana Stupin, MD, PhD、Faculty of Medicine Osijek, Josip Juraj Strossmayer of Osijek
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年4月1日
初级完成 (估计的)
2029年4月30日
研究完成 (估计的)
2029年9月30日
研究注册日期
首次提交
2026年7月22日
首先提交符合 QC 标准的
2026年7月22日
首次发布 (实际的)
2026年7月27日
研究记录更新
最后更新发布 (实际的)
2026年7月27日
上次提交的符合 QC 标准的更新
2026年7月22日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- HYPER-endoEV-pregnancy
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