DNA Double-strand Breaks After SPECT (DSB-SPECT)
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ClinicalTrials.gov Identifier: NCT01380821 |
Recruitment Status
:
Completed
First Posted
: June 27, 2011
Last Update Posted
: May 3, 2013
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Ionizing radiation has a number of harmful effects in humans. The most important among these is the induction of cancer. It is assumed that damage to DNA in the nucleus of a single cell can induce cancer. Among the different types of lesions inducted, DNA double-strand breaks (DSBs) are considered to be the most relevant effects that can initiate carcinogenesis.
The investigators are already conducting several other studies to prospectively compare the inducted DSBs by coronary CT-angiography and conventional coronary angiography. Extending these examinations to investigate the induced DSBs by myocardial scintigraphy allows a comparison of all three relevant imaging methods of the heart that incorporate ionizing radiation.
To evaluate this, the investigators are planning to examine patients who are scheduled for a clinically indicated myocardial scintigraphy. These examinations are routinely done by the Department of Nuclear Medicine in either a 1-day or a 2-day protocol according to the diagnostic reference values of the Federal Department for Radiological Protection. Blood samples will be taken from these patients at predefined time steps before and after the examination and DNA double-strand breaks will be determined from these blood samples specifically considering the applied activity of the tracer and the exposition kinetics.
Condition or disease | Intervention/treatment |
---|---|
Coronary Artery Disease | Radiation: Myocardial SPECT |
Study Type : | Observational |
Actual Enrollment : | 40 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | DNA Double-strand Breaks Following Myocardial Scintigraphy |
Study Start Date : | March 2011 |
Actual Primary Completion Date : | January 2013 |
Actual Study Completion Date : | January 2013 |
Group/Cohort | Intervention/treatment |
---|---|
SPECT
Patients clinically indicated to undergo myocardial SPECT in our institution.
|
Radiation: Myocardial SPECT
Myocardial SPECT according to clinical standards for patients with a clinical indication to undergo this imaging test.
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- Radiation-induced DNA double-strand breaks after myocardial scintigraphy. [ Time Frame: 48 hours ]DNA double-strand breaks will be measured before and up to 48 hours after radiation.
- Comparison of radiation-induced DSBs with activity used for myocardial scintigraphy. [ Time Frame: Activity will be measured 5 min and 1h after injection of the technetium tracer for SPECT. ]DNA double-strand breaks will be compared with injected activity.

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Ages Eligible for Study: | 19 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- myocardial SPECT clinically indicated
Exclusion Criteria:
- acute leukaemia or lymphoma
- radiation or chemotherapy in the last 6 months
- x-ray or scintigraphy within the last 3 days
- age below 18 years
- eGFR of below 60 ml/min

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01380821
Germany | |
Charité | |
Berlin, Germany, 10117 |
Principal Investigator: | Marc Dewey | Charite University, Berlin, Germany |
Publications:
Responsible Party: | Marc Dewey, Charité |
ClinicalTrials.gov Identifier: | NCT01380821 History of Changes |
Other Study ID Numbers: |
EA4/004/11 |
First Posted: | June 27, 2011 Key Record Dates |
Last Update Posted: | May 3, 2013 |
Last Verified: | April 2013 |
Keywords provided by Charite University, Berlin, Germany:
clinical indication for myocardial SPECT suspected or known coronary artery disease |
Additional relevant MeSH terms:
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |