Impact of Antioxidant Agents on the Number of DNA Double-strand Breaks After Radiation-based Cardiac Examinations
NCT ID: NCT01578395
Last Updated: 2012-12-06
Study Results
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Basic Information
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COMPLETED
PHASE2
102 participants
INTERVENTIONAL
2012-04-30
2012-11-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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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)
Low-dose radiation exposure
what: Cardiac CT; dosage: approx. 2-3 mSv; frequency: once
High-dose radiation exposure
what: cardiac catheterization procedures; dosage: approx. 75 mSv; frequency: once
No radiation exposure
Subjects not undergoing any radiation exposure
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)
Low-dose radiation exposure
what: Cardiac CT; dosage: approx. 2-3 mSv; frequency: once
High-dose radiation exposure
what: cardiac catheterization procedures; dosage: approx. 75 mSv; frequency: once
No radiation exposure
Subjects not undergoing any radiation exposure
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)
Low-dose radiation exposure
what: Cardiac CT; dosage: approx. 2-3 mSv; frequency: once
High-dose radiation exposure
what: cardiac catheterization procedures; dosage: approx. 75 mSv; frequency: once
No radiation exposure
Subjects not undergoing any radiation exposure
Interventions
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Low-dose radiation exposure
what: Cardiac CT; dosage: approx. 2-3 mSv; frequency: once
High-dose radiation exposure
what: cardiac catheterization procedures; dosage: approx. 75 mSv; frequency: once
No radiation exposure
Subjects not undergoing any radiation exposure
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
Yes
Sponsors
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University of Zurich
OTHER
Responsible Party
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Principal Investigators
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Philipp Kaufmann, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Zurich, Division of Nuclear Medicine
Locations
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University Hospital Zurich, Division of Nuclear Medicine
Zurich, Canton of Zurich, Switzerland
Countries
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Other Identifiers
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KEK-ZH-NR: 2010-0352
Identifier Type: -
Identifier Source: org_study_id