Focus of the Study: DNA Damage Due to Medical Diagnostic X-ray Clinical Trial
Official title:
Randomized, Double-blinded, Placebo-controlled, Single Center, and Prospective Phase II Clinical Trial to Analyze the Effects of Antioxidant Agents on DNA Double-strand Breaks in Patients After Radiation-based Cardiac Examinations
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention