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

NCT02617888 | Completed Results

• 1 other identifier: 362425
• Study Type: interventional
• Target: 228
• Locations: 0 countries
• Sites: N/A

Brief Summary

Purpose

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

Conditions

Coronary Artery Disease; Chest Pain

Keywords

radiation; cardiac computed tomography; CCTA; breast shielding; Myocardial perfusion scintigraphy; MPS; Invasive coronary angiography; ICA

Outcome Measures

Primary Outcomes (1)

• Number of Excess Double-strand DNA Break Foci Per Cell in Peripheral Blood Samples 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.

  Change from baseline double strand DNA breaks at 30 minutes post-imaging

Study Arms (3)

CCTA Breast Shields

ACTIVE COMPARATOR

Within female subset, randomization to wearing bismuth breast shield.

Radiation: CCTA ~ BREAST SHIELDS

CCTA No Breast Shields

NO INTERVENTION

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

Observational Arm

NO INTERVENTION

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

Interventions

CCTA ~ BREAST SHIELDS RADIATION

Breast shield placement (randomized) among women.

Also known as: BISMUTH BREAST SHIELDS

CCTA Breast Shields

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Walter Reed National Military Medical Center: lead

MeSH Terms

Conditions

Coronary Artery Disease; Chest Pain

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Participants were enrolled at one center and using one CT scanner, variable shield types and shield sizes were not studied, and further work is needed to examine tissue-specific responses to radiation and shielding.

Results Point of Contact

• Title: Michael K. Cheezum, MD
• Organization: Ft. Belvoir Community Hospital

Michael.k.cheezum.mil@mail.mil

571-231-2159

Study Officials

• Todd C Villines, MD

  WRNMMC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cardiovascular Research

Study Record Dates

• First Submitted: November 19, 2015
• First Posted: December 1, 2015
• Study Start: March 1, 2011
• Primary Completion: September 1, 2015
• Study Completion: December 1, 2015
• Last Updated: July 11, 2017
• Results First Posted: January 19, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share