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

Primary Purpose

Coronary Artery Disease, Chest Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CCTA ~ BREAST SHIELDS
Sponsored by
Walter Reed National Military Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring radiation, cardiac computed tomography, CCTA, breast shielding, Myocardial perfusion scintigraphy, MPS, Invasive coronary angiography, ICA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    No Intervention

    No Intervention

    Arm Label

    CCTA Breast Shields

    CCTA No Breast Shields

    Observational Arm

    Arm Description

    Within female subset, randomization to wearing bismuth breast shield.

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

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    November 19, 2015
    Last Updated
    June 12, 2017
    Sponsor
    Walter Reed National Military Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02617888
    Brief Title
    Effects of Heart Imaging Radiation on DNA Double-Stranded Breaks in Blood Lymphocytes and Hair Follicle Cells
    Official Title
    The HEART BREAK Study: Effects of Heart Imaging Radiation on DNA Double-Stranded Breaks in Blood Lymphocytes and Hair Follicle Cells
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2011 (undefined)
    Primary Completion Date
    September 2015 (Actual)
    Study Completion Date
    December 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Walter Reed National Military Medical Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Purpose 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Coronary Artery Disease, Chest Pain
    Keywords
    radiation, cardiac computed tomography, CCTA, breast shielding, Myocardial perfusion scintigraphy, MPS, Invasive coronary angiography, ICA

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    228 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    CCTA Breast Shields
    Arm Type
    Active Comparator
    Arm Description
    Within female subset, randomization to wearing bismuth breast shield.
    Arm Title
    CCTA No Breast Shields
    Arm Type
    No Intervention
    Arm Description
    Within female subset, randomization to wearing no bismuth breast shield (standard of care).
    Arm Title
    Observational Arm
    Arm Type
    No Intervention
    Arm Description
    Non-females undergoing CTA and subjects undergoing cardiac catheterization and nuclear medicine testing.
    Intervention Type
    Radiation
    Intervention Name(s)
    CCTA ~ BREAST SHIELDS
    Other Intervention Name(s)
    BISMUTH BREAST SHIELDS
    Intervention Description
    Breast shield placement (randomized) among women.
    Primary Outcome Measure Information:
    Title
    Number of Excess Double-strand DNA Break Foci Per Cell in Peripheral Blood Samples Post-imaging
    Description
    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.
    Time Frame
    Change from baseline double strand DNA breaks at 30 minutes post-imaging

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Todd C Villines, MD
    Organizational Affiliation
    WRNMMC
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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