跳至主要内容
临床试验/NCT07363187
NCT07363187尚未招募不适用

Evaluation of Microvascular Changes by Nailfold Capillaroscopy and Serum ADMA, Von Willebrand Factor, Hs-CRP, and D-dimer Levels in Healthcare Workers Exposed to Chronic Low-Dose Ionizing Radiation

Istanbul Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2026年2月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
Microvascular Changes Assessed by Nailfold Capillaroscopy

研究概览

简要总结

Chronic occupational exposure to low-dose ionizing radiation may lead to subclinical endothelial dysfunction and early microvascular alterations in healthcare workers. Nailfold capillaroscopy is a non-invasive method that allows direct visualization of microcirculatory changes. This observational study aims to evaluate microvascular alterations using nailfold capillaroscopy and to assess their association with serum endothelial and inflammatory biomarkers, including asymmetric dimethylarginine (ADMA), von Willebrand factor (vWF), high-sensitivity C-reactive protein (hs-CRP), and D-dimer levels. Healthcare workers with chronic low-dose radiation exposure will be compared with non-exposed controls. The study seeks to improve understanding of early vascular effects of occupational radiation exposure.

详细描述

Chronic occupational exposure to low-dose ionizing radiation may result in subclinical endothelial dysfunction and early microvascular alterations, even in the absence of overt clinical disease. Healthcare workers employed in medical departments where ionizing radiation is routinely used are exposed to cumulative radiation over time. Identifying early vascular changes in this population is important for understanding potential long-term cardiovascular risks associated with occupational radiation exposure.

Nailfold capillaroscopy is a non-invasive and reproducible imaging technique that enables direct visualization of the microcirculation and allows detailed assessment of capillary density, morphology, and structural abnormalities. Additionally, circulating endothelial and inflammatory biomarkers such as asymmetric dimethylarginine (ADMA), von Willebrand factor (vWF), high-sensitivity C-reactive protein (hs-CRP), and D-dimer may reflect endothelial dysfunction, inflammation, and prothrombotic activity at a subclinical level.

This single-center, observational, cross-sectional study will include healthcare workers with chronic occupational exposure to low-dose ionizing radiation and a control group of healthcare workers without radiation exposure from the same institution. Demographic characteristics, occupational exposure duration, and work-related radiation exposure history will be recorded for all participants.

All participants will undergo nailfold capillaroscopy evaluation using standardized assessment criteria, including capillary density, tortuosity, dilatation, dystrophic changes, avascular areas, microhemorrhages, neoangiogenesis, and subpapillary plexus visibility. Venous blood samples will be collected to measure serum ADMA, vWF, hs-CRP, and D-dimer levels using routine laboratory methods and enzyme-linked immunosorbent assay techniques, as appropriate.

The primary objective of this study is to identify microvascular changes detected by nailfold capillaroscopy in healthcare workers exposed to chronic low-dose ionizing radiation. Secondary objectives include evaluating the association between capillaroscopic findings, serum biomarkers, and occupational radiation exposure characteristics. The findings of this study may contribute to improved understanding of early vascular effects of chronic occupational radiation exposure and support the use of nailfold capillaroscopy as a practical screening tool in exposed populations.

研究设计

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

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthcare workers aged between 18 and 60 years.
  • For the control group: Employment in a healthcare institution with either occupational exposure to low-dose ionizing radiation or no occupational radiation exposure.
  • For the exposed group: chronic occupational exposure to ionizing radiation for at least 3 years.
  • Willingness and ability to provide written informed consent.
  • Ability to comply with study procedures, including nailfold capillaroscopy and blood sample collection.

排除标准

  • History of cardiovascular disease, cerebrovascular disease, or peripheral vascular disease.
  • Presence of systemic diseases that may affect microvascular structure or endothelial function, including diabetes mellitus, uncontrolled hypertension, dyslipidemia, or chronic kidney disease.
  • Known autoimmune, connective tissue, or systemic inflammatory diseases (e.g., systemic sclerosis, lupus erythematosus, vasculitis).
  • Active infection or acute inflammatory condition at the time of enrollment.
  • Use of systemic medications that may affect endothelial function or microcirculation within the past 4 weeks, including vasodilators, antihypertensive agents, statins, antiplatelet or anticoagulant drugs.
  • Current smoking or history of smoking within the past 6 months.
  • Pregnancy or breastfeeding.
  • History of malignancy or current cancer treatment.
  • Previous finger trauma, surgery, or local conditions affecting the nailfold area that may interfere with capillaroscopic evaluation.

研究组 & 干预措施

Radiation-Exposed Healthcare Workers

Healthcare workers with chronic occupational exposure to low-dose ionizing radiation as part of their routine professional activities in medical departments where radiation is used.

Non-Exposed Control Group

Healthcare workers without occupational exposure to ionizing radiation, working in departments where radiation-based procedures are not used.

结局指标

主要结局

Microvascular Changes Assessed by Nailfold Capillaroscopy

时间窗: Baseline (single assessment at study visit

Microvascular alterations will be evaluated using nailfold capillaroscopy, including capillary density and morphological abnormalities such as tortuosity, dilatation, elongated capillaries, dystrophic changes, avascular areas, microhemorrhages, neoangiogenesis, and subpapillary plexus visibility. Capillaroscopic findings will be assessed using standardized semi-quantitative scoring criteria

次要结局

  • Serum Asymmetric Dimethylarginine (ADMA) Level(Baseline (single assessment at study visit))
  • Serum von Willebrand Factor (vWF) Level(Baseline (single assessment at study visit))
  • Serum High-Sensitivity C-Reactive Protein (hs-CRP) Level(Baseline (single assessment at study visit))
  • Serum D-dimer Level(Baseline (single assessment at study visit))
  • Correlation Between Nailfold Capillaroscopy Scores and Serum Biomarker Levels(Baseline (cross-sectional analysis))
  • Correlation Between Occupational Radiation Exposure and Microvascular and Serum Biomarker Measurements(Baseline (cross-sectional analysis))

研究者

发起方
Istanbul Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Elif Banu Yildiran

Dermatology Resident Physician

Istanbul Training and Research Hospital

研究点 (1)

Loading locations...

相似试验