DNA Double-strand Breaks After SPECT

NCT01380821 | Completed

• 1 other identifier: EA4/004/11
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

clinical indication for myocardial SPECT; suspected or known coronary artery disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Comparison of radiation-induced DSBs with activity used for myocardial scintigraphy.

  Activity will be measured 5 min and 1h after injection of the technetium tracer for SPECT.

Study Arms (1)

SPECT

Patients clinically indicated to undergo myocardial SPECT in our institution.

Radiation: Myocardial SPECT

Interventions

Myocardial SPECT RADIATION

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

SPECT

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients clinically indicated to undergo myocardial SPECT.

You may qualify if:

• myocardial SPECT clinically indicated

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité

Berlin, State of Berlin, 10117, Germany

Location

Related 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.

  PMID: 18710979 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Marc Dewey

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 22, 2011
• First Posted: June 27, 2011
• Study Start: March 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: May 3, 2013

Record last verified: 2013-04

Locations

DE (1)