Completed

NCT Number: NCT01578395

Impact of Antioxidant Agents on the Number of DNA Double-strand Breaks 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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Key information

Conditions

Focus of the Study: DNA Damage Due to Medical Diagnostic X-ray

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital Zurich, Division of Nuclear Medicine

Zurich, Canton of Zurich, 8091, Switzerland

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Low-dose radiation exposure

Radiation

what: Cardiac CT; dosage: approx. 2-3 mSv; frequency: once

High-dose radiation exposure

Radiation

what: cardiac catheterization procedures; dosage: approx. 75 mSv; frequency: once

No radiation exposure

Other

Subjects not undergoing any radiation exposure

Primary outcomes

Change in the number of DNA double-strand breaks under influence of antioxidant agents vs. placebo

Time frame: 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 outcomes

Change in the number of DNA double-strand breaks between n-acetylcysteine and ascorbic acid

Time frame: 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

Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study 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

Important dates

Study start: 2012
Primary completion: 2012
Study completion: 2012
First posted: Apr 16, 2012
Registry last updated: Dec 6, 2012

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.