Focus of the Study: DNA Damage Due to Medical Diagnostic X-ray
Conditions
Brief summary
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.
Interventions
RADIATIONLow-dose radiation exposure
what: Cardiac CT; dosage: approx. 2-3 mSv; frequency: once
RADIATIONHigh-dose radiation exposure
what: cardiac catheterization procedures; dosage: approx. 75 mSv; frequency: once
OTHERNo radiation exposure
Subjects not undergoing any radiation exposure
Sponsors
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or Female * 18-70 years of age * European origin * Non-smoker * 30 patients with high-dose radiation exposure from a cardiac examination * 30 patients with low-dose radiation exposure from a cardiac examination * 30 subjects without radiation exposure * Given written informed consent * Ability to participate in the study
Exclusion criteria
* no known intolerance against one of the applied study drugs or against substances used for formulation of one of the study drugs or against other drugs with similar chemical structures as one of the study drugs * Leukemia * Lymphoma * Radio- or chemotherapy * Severe renal failure (GFR\<30 ml/min) * Positive pregnancy test or lactation * Radiation-based examination within the last 3 days * Known glucose-6-phosphate-dehydrogenase deficiency * Known nephrolithiasis (calciumoxalate calculus) * Intake of barbiturates, tetracyclines, corticosteroids within the last 4 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the number of DNA double-strand breaks under influence of antioxidant agents vs. placebo | Baseline blood draw before radiation exposure and follow-up blood draw approx. 30 minutes after radiation exposure | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the number of DNA double-strand breaks between n-acetylcysteine and ascorbic acid | Baseline blood draw before radiation exposure and follow-up blood draw approx. 30 minutes after radiation exposure | 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). |
| Change in the number of DNA double-strand breaks between no, low, and high radiation exposure | Baseline blood draw before radiation exposure and follow-up blood draw approx. 30 minutes after 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). |
Countries
Switzerland
Outcome results
None listed