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Effects of Heart Imaging Radiation on DNA Double-Stranded Breaks in Blood Lymphocytes and Hair Follicle Cells

Not Applicable
Completed
Conditions
Coronary Artery Disease
Chest Pain
Interventions
Radiation: CCTA ~ BREAST SHIELDS
Registration Number
NCT02617888
Lead Sponsor
Walter Reed National Military Medical Center
Brief Summary

Purpose

1. To investigate the effects of cardiac imaging radiation on the induction of DNA double-strand breaks by enumerating gamma-H2AX foci in blood lymphocytes and plucked hair follicle cells.

2. To estimate whether the use of breast shields in cardiac computed tomographic angiography (CCTA) limits the effective radiation exposure of breast tissue.

Detailed Description

The primary objective of the study is to analyze blood and hair samples from patients undergoing cardiac imaging to estimate radiation exposure levels as well as their biological effects (i.e. to determine the degree of genotoxicity by measuring the amounts of DNA double-strand breaks).

The secondary objective is to investigate whether the use of in-plane breast shielding in female patients undergoing CT angiography (CCTA) limits the radiation exposure of breast tissue and subsequent DNA damage in blood lymphocytes and hair follicle cells.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
228
Inclusion Criteria
  • Adult male and female adult subjects (age greater than 18 years)
  • Referred for cardiac computed tomography angiography (CCTA), myocardial perfusion scintigraphy (MPS), or diagnostic invasive coronary angiography (ICA).
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Exclusion Criteria
  • Female patients that identify themselves as pregnant or have a positive pregnancy test prior to cardiac imaging.
  • History (present or past) of leukemia or lymphoma.
  • History of radiation therapy
  • X-ray examination or scintigraphy within the last 72 hours.
  • History of coronary revascularization (coronary artery bypass grafting or percutaneous coronary intervention)
  • Patients undergoing percutaneous coronary intervention at completion of diagnostic left heart catheterization
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
CCTA Breast ShieldsCCTA ~ BREAST SHIELDSWithin female subset, randomization to wearing bismuth breast shield.
Primary Outcome Measures
NameTimeMethod
Number of Excess Double-strand DNA Break Foci Per Cell in Peripheral Blood Samples Post-imagingChange from baseline double strand DNA breaks at 30 minutes post-imaging

The amount of excess DNA double-strand break foci per cell after cardiac computed tomographic angiography (CCTA) in female patients with and without breast shields, minus the amount of foci prior to CCTA. In addition, changes in DNA double-strand breaks from baseline following cardiac testing in the observational arm is being assessed in an observational manner.

Secondary Outcome Measures
NameTimeMethod
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