Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01380821
First received: June 22, 2011
Last updated: May 2, 2013
Last verified: April 2013
History of Changes
  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:

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 ] [ Designated as safety issue: Yes ]
    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. ] [ Designated as safety issue: No ]
    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
Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:

Responsible Party: Marc Dewey, Charité
ClinicalTrials.gov Identifier: NCT01380821     History of Changes
Other Study ID Numbers: EA4/004/11 
Study First Received: June 22, 2011
Last Updated: May 2, 2013
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on September 23, 2016