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Impact of Antioxidant Agents on the Number of DNA Double-strand Breaks After Radiation-based Cardiac Examinations

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ClinicalTrials.gov Identifier: NCT01578395
Recruitment Status : Completed
First Posted : April 16, 2012
Last Update Posted : December 6, 2012
Sponsor:
Information provided by (Responsible Party):
University of Zurich

April 12, 2012
April 16, 2012
December 6, 2012
April 2012
November 2012   (Final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01578395 on ClinicalTrials.gov Archive Site
  • 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).
Same as current
Not Provided
Not Provided
 
Impact of Antioxidant Agents on the Number of DNA Double-strand Breaks After Radiation-based Cardiac Examinations
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Focus of the Study: DNA Damage Due to Medical Diagnostic X-ray
  • Radiation: Low-dose radiation exposure
    what: Cardiac CT; dosage: approx. 2-3 mSv; frequency: once
  • Radiation: High-dose radiation exposure
    what: cardiac catheterization procedures; dosage: approx. 75 mSv; frequency: once
  • Other: No radiation exposure
    Subjects not undergoing any radiation exposure
  • Experimental: N-acetylcysteine
    This arm consists of 30 patients who will receive 1200mg n-acetylcysteine dissolved in 50ml NaCl 0.9% iv before either low-dose (10 patients) or high-dose (10 patients) radiation exposure, or no radiation exposure (10 patients)
    Interventions:
    • Radiation: Low-dose radiation exposure
    • Radiation: High-dose radiation exposure
    • Other: No radiation exposure
  • Experimental: Ascorbic acid
    This arm consists of 30 patients who will receive 3000 mg ascorbic acid dissolved in 50 ml NaCl 0.9% iv before either low-dose (10 patients) or high-dose (10 patients) radiation exposure, or no radiation exposure (10 patients)
    Interventions:
    • Radiation: Low-dose radiation exposure
    • Radiation: High-dose radiation exposure
    • Other: No radiation exposure
  • Placebo Comparator: Sodium Chloride (NaCl)
    This arm consists of 30 patients who will receive 50 ml NaCl 0.9% iv before either low-dose (10 patients) or high-dose (10 patients) radiation exposure, or no radiation exposure (10 patients)
    Interventions:
    • Radiation: Low-dose radiation exposure
    • Radiation: High-dose radiation exposure
    • Other: No radiation exposure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
102
90
November 2012
November 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
 
NCT01578395
KEK-ZH-NR: 2010-0352
Yes
Not Provided
Not Provided
University of Zurich
University of Zurich
Not Provided
Principal Investigator: Philipp Kaufmann, MD University Hospital Zurich, Division of Nuclear Medicine
University of Zurich
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP