Coronary Artery DiseaseNCT02617888
Effects of Heart Imaging Radiation on DNA Double-Stranded Breaks in Blood Lymphocytes and Hair Follicle Cells
A study testing CCTA ~ BREAST SHIELDS in people with Coronary Artery Disease and Chest Pain, run by Walter Reed National Military Medical Center.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Chest Pain
- What is being tested?
- CCTA ~ BREAST SHIELDS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- No sites listed yet
- Study dates
- Mar 2011to Dec 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
About this study
Official title: The HEART BREAK Study: Effects of Heart Imaging Radiation on DNA Double-Stranded Breaks in Blood Lymphocytes and Hair Follicle Cells
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.
Read the 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.
- Conditions
- Coronary Artery Disease, Chest Pain
- Being tested
- CCTA ~ BREAST SHIELDS
- Keywords
- radiation, cardiac computed tomography, CCTA, breast shielding, Myocardial perfusion scintigraphy, MPS, Invasive coronary angiography, ICA
- Medical subject headings
- Coronary Artery Disease, Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CCTA ~ BREAST SHIELDSRadiation
Also called BISMUTH BREAST SHIELDS
Breast shield placement (randomized) among women.
| Study group | Role | What they receive |
|---|---|---|
| CCTA Breast Shields | Active comparator | Within female subset, randomization to wearing bismuth breast shield. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline double strand DNA breaks at 30 minutes post-imaging
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2015 (estimated)
- Study startMar 2011
- Primary completionSep 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walter Reed National Military Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Todd C. Villines, Walter Reed National Military Medical Center
- Investigators
- Todd C Villines, MD, Principal investigator, WRNMMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02617888
- Sponsor's protocol ID
- 362425
- Status last verified
- Jun 2017
- First submitted
- 19 Nov 2015
- Last updated
- 11 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The HEART BREAK Study: Effects of Heart Imaging Radiation on DNA Double-Stranded Breaks in Blood Lymphocytes and Hair Follicle Cells
- ClinicalTrials.gov ID
- NCT02617888
- Acronym / sponsor ID
- 362425
- Conditions
- Coronary Artery Disease, Chest Pain
- Keywords
- radiation, cardiac computed tomography, CCTA, breast shielding, Myocardial perfusion scintigraphy, MPS, Invasive coronary angiography, ICA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Walter Reed National Military Medical CenterUS federal agency
- Study start
- Mar 2011
- Primary completion
- Sep 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 1 Dec 2015 (estimated)
- Results
- Posted 19 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CCTA Breast Shields | Active comparator | Radiation: CCTA ~ BREAST SHIELDSWithin 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CCTA ~ BREAST SHIELDSAlso: BISMUTH BREAST SHIELDSBreast shield placement (randomized) among women. | Radiation | CCTA Breast Shields |
Primary outcome
Number of Excess Double-strand DNA Break Foci Per Cell in Peripheral Blood Samples Post-imaging
Time frame: Change from baseline double strand DNA breaks at 30 minutes 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Todd C Villines, MD principal investigator
WRNMMC
Questions about this trial
What is this clinical trial studying?
A study testing CCTA ~ BREAST SHIELDS in people with Coronary Artery Disease and Chest Pain, run by Walter Reed National Military Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Excess Double-strand DNA Break Foci Per Cell in Peripheral Blood Samples Post-imaging (time frame: Change from baseline double strand DNA breaks at 30 minutes post-imaging). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2017.