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

NCT01578395 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2012-12-06

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • University of Zurich

    lead OTHER

Principal Investigators

  • Philipp Kaufmann, MD · University Hospital Zurich, Division of Nuclear Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01578395 on ClinicalTrials.gov