Trial with medicinal products Recent studies revealed that radiation-based procedures in patients may lead to DNA double-strand breaks in human blood lymphocytes. Additionally, ex vivo studies with human blood lymphocytes have shown a protective effect of antioxidant agents which have been described to decrease the number of DNA double-strand breaks. This study represents a prospective, double-blinded, randomized, single center, and placebo-controlled phase II clinical trial which analyzes the capability of antioxidant agents to decrease the number of DNA double-strand breaks in human blood lymphocytes in patients undergoing radiation-based cardiac examinations (30 patients with high-dose radiation exposure, 30 patients with low-dose radiation exposure, and 30 subjects without radiation exposure). A protective effect of antioxidant drugs in patients undergoing radiation-based examinations could therefore change patient management and would provide an important clinical impact.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
102
what: Cardiac CT; dosage: approx. 2-3 mSv; frequency: once
what: cardiac catheterization procedures; dosage: approx. 75 mSv; frequency: once
Subjects not undergoing any radiation exposure
University Hospital Zurich, Division of Nuclear Medicine
Zurich, Canton of Zurich, Switzerland
Change in the number of DNA double-strand breaks under influence of antioxidant agents vs. placebo
Potential change (before and after radiation exposure) in the number of DNA double-strand breaks under the influence of n-acetylcystein or ascorbic acid will be measured by qualitative and quantitative immunofluorescence studies (immunofluorescence microscopy and FACS analysis) and will be compared to study patients administered with placebo (using the same quantifiaction tools).
Time frame: Baseline blood draw before radiation exposure and follow-up blood draw approx. 30 minutes after radiation exposure
Change in the number of DNA double-strand breaks between n-acetylcysteine and ascorbic acid
Potential change (before and after radiation exposure) in the number of DNA double-strand breaks from patients administered with n-acetylcysteine compared to the number of DNA double-strand breaks from patients administered with ascorbic acid. The change in the number of DNA double-strand breaks will be measured by qualitative and quantitative immunofluorescence studies (immunofluorescence microscopy and FACS analysis).
Time frame: Baseline blood draw before radiation exposure and follow-up blood draw approx. 30 minutes after radiation exposure
Change in the number of DNA double-strand breaks between no, low, and high radiation exposure
Potential change (before and after radiation exposure) in the number of DNA double-strand breaks between the different study interventions (low-dose radiation exposure, high-dose radiation exposure, and no radiation exposure). The change in the number of DNA double-strand breaks will be measured by qualitative and quantitative immunofluorescence studies (immunofluorescence microscopy and FACS analysis).
Time frame: Baseline blood draw before radiation exposure and follow-up blood draw approx. 30 minutes after radiation exposure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.