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

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. Identifier: NCT01380821
Recruitment Status : Completed
First Posted : June 27, 2011
Last Update Posted : May 3, 2013
Information provided by:
Charite University, Berlin, Germany

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 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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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.

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.

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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.

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

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 identifier (NCT number): NCT01380821

Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Principal Investigator: Marc Dewey Charite University, Berlin, Germany

Responsible Party: Marc Dewey, Charité 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
Arterial Occlusive Diseases
Vascular Diseases