DNA Double-strand Breaks After SPECT (DSB-SPECT)

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 Design

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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

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Outcome Measures

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Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	19 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients clinically indicated to undergo myocardial SPECT.

Criteria

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

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Germany
Charité
Berlin, Germany, 10117

Sponsors and Collaborators

Charite University, Berlin, Germany

Investigators

Principal Investigator:	Marc Dewey	Charite University, Berlin, Germany

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Geisel D, Heverhagen JT, Kalinowski M, Wagner HJ. DNA double-strand breaks after percutaneous transluminal angioplasty. Radiology. 2008 Sep;248(3):852-9. doi: 10.1148/radiol.2483071686.

Responsible Party:	Marc Dewey, Charité
ClinicalTrials.gov Identifier:	NCT01380821 History of Changes
Other Study ID Numbers:	EA4/004/11
First Posted:	June 27, 2011
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