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NCT Number: NCT07363187

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul Training and Research Hospital

Istanbul, 34000, Turkey (Türkiye)

Location contact

Ayse Esra Koku AKsu, MD, Prof

CONTACT

[email protected]

+905059126069

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Microvascular Changes Assessed by Nailfold Capillaroscopy

    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

Secondary outcomes

  1. Serum Asymmetric Dimethylarginine (ADMA) Level

    Time frame: Baseline (single assessment at study visit)

    Serum levels of asymmetric dimethylarginine (ADMA) will be measured as a marker of endothelial dysfunction.

  2. Serum von Willebrand Factor (vWF) Level

    Time frame: Baseline (single assessment at study visit)

    Serum von Willebrand factor (vWF) levels will be measured to assess endothelial activation and vascular injury.

  3. Serum High-Sensitivity C-Reactive Protein (hs-CRP) Level

    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.

  4. Serum D-dimer Level

    Time frame: Baseline (single assessment at study visit)

    Serum D-dimer levels will be measured to evaluate prothrombotic activity.

  5. Correlation Between Nailfold Capillaroscopy Scores and Serum Biomarker Levels

    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.

  6. Correlation Between Occupational Radiation Exposure and Microvascular and Serum Biomarker Measurements

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Duygu Yamen, MD

CONTACT

[email protected]

+905064016136

Elif Banu Yildiran, MD

CONTACT

[email protected]

+905303552144

Sponsors and collaborators

Lead sponsor

Istanbul Training and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 23, 2026
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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