DNA Double-strand Breaks After SPECT

Coronary Artery Disease Clinical Trial

— DSB-SPECT  

Official title:

DNA Double-strand Breaks Following Myocardial Scintigraphy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01380821
• Other study ID #: EA4/004/11
• Status: Completed
• Phase: N/A
• First received: June 22, 2011
• Last updated: May 2, 2013
• Start date: March 2011
• Est. completion date: January 2013

Study information

• Verified date: April 2013
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Radiation:
• Myocardial SPECT
Myocardial SPECT according to clinical standards for patients with a clinical indication to undergo this imaging test.

Locations

Country	Name	City	State
Germany	Charité	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiation-induced DNA double-strand breaks after myocardial scintigraphy.	DNA double-strand breaks will be measured before and up to 48 hours after radiation.	48 hours	Yes
Secondary	Comparison of radiation-induced DSBs with activity used for myocardial scintigraphy.	DNA double-strand breaks will be compared with injected activity.	Activity will be measured 5 min and 1h after injection of the technetium tracer for SPECT.	No