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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| N-acetylcysteine | Experimental | 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) |
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| Ascorbic acid | Experimental | 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) |
|
| Sodium Chloride (NaCl) | Placebo Comparator | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-dose radiation exposure | Radiation | what: Cardiac CT; dosage: approx. 2-3 mSv; frequency: once |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in the number of DNA double-strand breaks under influence of antioxidant agents vs. placebo | 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). | Baseline blood draw before radiation exposure and follow-up blood draw approx. 30 minutes after radiation exposure |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the number of DNA double-strand breaks between n-acetylcysteine and ascorbic acid | 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). |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philipp Kaufmann, MD | University Hospital Zurich, Division of Nuclear Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Zurich, Division of Nuclear Medicine | Zurich | Canton of Zurich | 8091 | Switzerland |
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| High-dose radiation exposure | Radiation | what: cardiac catheterization procedures; dosage: approx. 75 mSv; frequency: once |
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| No radiation exposure | Other | Subjects not undergoing any radiation exposure |
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| Baseline blood draw before radiation exposure and follow-up blood draw approx. 30 minutes after radiation exposure |
| Change in the number of DNA double-strand breaks between no, low, and high 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). | Baseline blood draw before radiation exposure and follow-up blood draw approx. 30 minutes after radiation exposure |
| ID | Term |
|---|---|
| D000069079 | Radiation Exposure |
| ID | Term |
|---|---|
| D011827 | Radiation |
| D055585 | Physical Phenomena |
| D004781 | Environmental Exposure |
| D004787 | Environmental Pollution |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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