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Набор скоро начнётся NCT07363187

Nailfold Capillaroscopy and Endothelial Biomarkers in Healthcare Workers Exposed to Chronic Low-Dose Ionizing Radiation

Наблюдательное Microvascular Dysfunction Endothelial Dysfunction Occupational Radiation Exposure

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Microvascular Dysfunction, Endothelial Dysfunction, Occupational Radiation Exposure. Базовые параметры: 18 лет — 60 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

  • Microvascular Changes Assessed by Nailfold Capillaroscopy [Срок оценки: Baseline (single assessment at study visit]
Вторичные конечные точки (6)
  • Serum Asymmetric Dimethylarginine (ADMA) Level [Срок оценки: Baseline (single assessment at study visit)]
  • Serum von Willebrand Factor (vWF) Level [Срок оценки: Baseline (single assessment at study visit)]
  • Serum High-Sensitivity C-Reactive Protein (hs-CRP) Level [Срок оценки: Baseline (single assessment at study visit)]
  • Serum D-dimer Level [Срок оценки: Baseline (single assessment at study visit)]
  • Correlation Between Nailfold Capillaroscopy Scores and Serum Biomarker Levels [Срок оценки: Baseline (cross-sectional analysis)]
  • Correlation Between Occupational Radiation Exposure and Microvascular and Serum Biomarker Measurements [Срок оценки: Baseline (cross-sectional analysis)]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Turkey (Türkiye) · 1 центр
  • Istanbul Training and Research Hospital — Istanbul

Идентификаторы

NCT: NCT07363187 · SBU-IEAH-EC274

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗