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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorIstanbul Training and Research Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

The study population will consist of healthcare workers aged 18 to 60 years employed at a tertiary care hospital. The exposed group will include healthcare workers with chronic occupational exposure to low-dose ionizing radiation, while the control group will include healthcare workers without occupational radiation exposure, working in non-radiation-related departments within the same institution. Participants will be recruited on a voluntary basis and will undergo a single study visit including nailfold capillaroscopy, blood sample collection, and completion of demographic and occupational exposure questionnaires.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

90 Participants
are grouped into 2 trial groups
Group A: Radiation-Exposed Healthcare Workers
Group B: Non-Exposed Control Group

Trial outcomes

Primary outcomes

1

Microvascular Changes Assessed by Nailfold Capillaroscopy

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

Secondary outcomes

1

Serum Asymmetric Dimethylarginine (ADMA) Level

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

Time frame
Baseline (single assessment at study visit)
2

Serum von Willebrand Factor (vWF) Level

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

Time frame
Baseline (single assessment at study visit)
3

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

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)
4

Serum D-dimer Level

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

Time frame
Baseline (single assessment at study visit)

Other outcomes

Sponsors and contacts

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