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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

228 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Coronary Artery Disease Chest Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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CCTA Breast Shields

Within female subset, randomization to wearing bismuth breast shield.

Group Type ACTIVE_COMPARATOR

CCTA ~ BREAST SHIELDS

Intervention Type RADIATION

Breast shield placement (randomized) among women.

CCTA No Breast Shields

Within female subset, randomization to wearing no bismuth breast shield (standard of care).

Group Type NO_INTERVENTION

No interventions assigned to this group

Observational Arm

Non-females undergoing CTA and subjects undergoing cardiac catheterization and nuclear medicine testing.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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CCTA ~ BREAST SHIELDS

Breast shield placement (randomized) among women.

Intervention Type RADIATION

Other Intervention Names

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BISMUTH BREAST SHIELDS

Eligibility Criteria

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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).

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No