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

Walter Reed National Military Medical Center

Status: Completed

Conditions: Coronary Artery Disease; Chest Pain

Treatments: Radiation: CCTA ~ BREAST SHIELDS

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT02617888

362425

Details and patient eligibility

About

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.

Full 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.

Enrollment: 228 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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228 participants in 3 patient groups

CCTA Breast Shields

Active Comparator group

Description:

Within female subset, randomization to wearing bismuth breast shield.

Treatment:

Radiation: CCTA ~ BREAST SHIELDS

CCTA No Breast Shields

No Intervention group

Description:

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

Observational Arm

No Intervention group

Description:

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