Istanbul Training and Research Hospital
Istanbul, 34000, Turkey (Türkiye)
NCT Number: NCT07363187
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.
Trial opening soon.
Get Notified18 year–60 year
All sexes
Observational
Istanbul, 34000, Turkey (Türkiye)
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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
Time frame: Baseline (single assessment at study visit)
Serum levels of asymmetric dimethylarginine (ADMA) will be measured as a marker of endothelial dysfunction.
Time frame: Baseline (single assessment at study visit)
Serum von Willebrand factor (vWF) levels will be measured to assess endothelial activation and vascular injury.
Time frame: Baseline (single assessment at study visit)
Serum high-sensitivity C-reactive protein (hs-CRP) levels will be measured as a marker of systemic inflammation.
Time frame: Baseline (single assessment at study visit)
Serum D-dimer levels will be measured to evaluate prothrombotic activity.
Time frame: Baseline (cross-sectional analysis)
The correlation between nailfold capillaroscopy findings and serum biomarker levels will be evaluated. Nailfold capillaroscopy parameters, including capillary density score and semi-quantitative morphological scores (tortuosity, dilatation, dystrophic changes, avascular areas, microhemorrhages, and neoangiogenesis), assessed using standardized nailfold capillaroscopy evaluation criteria, will be correlated with serum concentrations of asymmetric dimethylarginine (ADMA), von Willebrand factor (vWF), high-sensitivity C-reactive protein (hs-CRP), and D-dimer measured by laboratory assays. Correlation analysis will be performed to assess the relationship between microvascular structural alterations and biochemical markers of endothelial dysfunction, inflammation, and prothrombotic activity.
Time frame: Baseline (cross-sectional analysis)
The correlation between occupational radiation exposure and microvascular and biochemical parameters will be evaluated. Occupational radiation exposure will be assessed using self-reported work history, including duration of employment in radiation-related medical departments (years of exposure). Microvascular changes will be assessed by nailfold capillaroscopy using standardized semi-quantitative scoring systems, including capillary density score and morphological scores (tortuosity, dilatation, dystrophic changes, avascular areas, microhemorrhages, and neoangiogenesis). Biochemical parameters will include serum concentrations of asymmetric dimethylarginine (ADMA), von Willebrand factor (vWF), high-sensitivity C-reactive protein (hs-CRP), and D-dimer, measured by laboratory assays. Correlation analyses will be performed to evaluate the relationship between occupational radiation exposure duration and microvascular or serum biomarker measurements.
Contact information is provided by the study sponsor or research team.
Duygu Yamen, MD
CONTACT
Elif Banu Yildiran, MD
CONTACT
Istanbul Training and Research Hospital
Other Gov
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
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