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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01380821

First Posted: June 27, 2011

Last Update Posted: May 3, 2013

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

Charite University, Berlin, Germany

Purpose

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	Intervention
Coronary Artery Disease	Radiation: Myocardial SPECT


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	DNA Double-strand Breaks Following Myocardial Scintigraphy

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease Nuclear Scans

U.S. FDA Resources

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:

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:

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.


Enrollment:	40
Study Start Date:	March 2011
Study Completion Date:	January 2013
Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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.

Eligibility

Information from the National Library of Medicine

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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

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

Information from the National Library of Medicine

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

Locations


Germany
Charité
Berlin, Germany, 10117

Sponsors and Collaborators

Charite University, Berlin, Germany

Investigators


Principal Investigator:	Marc Dewey	Charite University, Berlin, Germany

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 Submitted:	June 22, 2011
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

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