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Purpose
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CCTA Breast Shields | Active Comparator | Within female subset, randomization to wearing bismuth breast shield. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CCTA ~ BREAST SHIELDS | Radiation | Breast shield placement (randomized) among women. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Todd C Villines, MD | WRNMMC | Principal Investigator |
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101 patients enrolled in intervention arms (breast shields). Other patients in observational arm (not completed analysis).
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| ID | Title | Description |
|---|---|---|
| FG000 | CCTA Breast Shields | Within female subset, randomization to wearing bismuth breast shield. . |
| FG001 | CCTA No Breast Shields | Within female subset, randomization to not wearing bismuth breast shield (standard of care). |
| FG002 | Observational | Non-female patients undergoing coronary CTA, patients undergoing nuclear cardiology studies and invasive coronary angiography. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CCTA Breast Shields | Within female subset, randomization to wearing bismuth breast shield. |
| BG001 | CCTA No Breast Shields | Within female subset, randomization to not wearing bismuth breast shield (standard of care). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Female patients 18 years or older who were clinically referred to undergo coronary CT angiography between August 2012 and July 2014 at Walter Reed National Military Medical Center (Bethesda, Maryland) were eligible for enrollment. | Posted | Mean | Standard Deviation | gamma-H2AX foci in blood lymphocytes | Change from baseline double strand DNA breaks at 30 minutes post-imaging |
|
30 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CCTA Breast Shields | Within female subset, randomization to wearing bismuth breast shield. . |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael K. Cheezum, MD | Ft. Belvoir Community Hospital | 571-231-2159 | Michael.k.cheezum.mil@mail.mil |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D002637 | Chest Pain |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| BG002 | Observational Arm | 1. Non-female patients undergoing coronary CTA; 2. Patients undergoing nuclear cardiology stress testing; 3. Patients undergoing invasive coronary angiography. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| BMI (kg/m^2) | Mean | Standard Deviation | kg/m^2 |
|
| Chest circumference (cm) | Mean | Standard Deviation | cm |
|
| Current smokers | Count of Participants | Participants |
|
| Heart rate (beats/min) | Mean | Standard Deviation | beats/min |
|
| OG001 | Breast Shields | Within female subset, randomization to wearing bismuth breast shield or not wearing bismuth breast shield (standard of care). CCTA: Breast shield placement (randomized) among women. |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | CCTA No Breast Shields | Within female subset, randomization to not wearing bismuth breast shield (standard of care). . | 0 | 51 | 0 | 51 |
| EG002 | Observational Arm | Observational evaluating the dose-related impact of radiation exposure from multiple sources and types on changes in double-stranded DNA breaks. | 0 | 127 | 0 | 127 |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |