Coronary Artery DiseaseNCT03253692
Prospective Multicenter Registry On Radiation Dose Estimates Of Cardiac CT Angiography in Daily Practice in 2017 (PROTECTION VI)
An observational study of Coronary Artery Disease and Coronary Disease, run by National Heart, Lung, and Blood Institute (NHLBI) at 3 sites in United States.
Trial summary
Background: CCTA is a common way to evaluate coronary artery disease. It stands for coronary computed tomography angiography. It uses scanning to look at the arteries that supply blood to the heart. It is noninvasive, widely available, and generally accurate. But it does expose people to radiation. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Coronary Artery Disease, Coronary Disease, Myocardial Ischemia
- How many people
- 66 participants
- Where
- 3 sitesUnited States
- Study dates
- 3 Oct 2017to 11 Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Data confirming the inclusion/exclusion criteria will be confirmed at the study visit. Overall, up to 100 subjects will be enrolled locally at the NIH. A member of the study team will review the CT procedures and confirm that the participants do not have any serious health problems or concomitant conditions or medications that would prevent them from having the CT. A member of the study team will perform a pregnancy test (if applicable) in female participants of childbearing potential. If you are nursing, you will be excluded from this study. All tests will follow NIH Clinical Center policies and clinical consent forms for individual tests may be obtained in addition to the study protocol consent as applicable. Sites outside the NIH will use similar standard of care procedures for cardiac CT eligibility.
Who may be able to join
- Clinical indication for cardiac CT angiography to evaluate coronary arteries or other cardiac structures
- Age equal to or greater than 18 years
- Able to understand and willing to sign the Informed Consent Form
Who cannot join
- 1) Female participants who are pregnant or nursing
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
University of Kentucky
Lexington, Kentucky, 40506
About this study
Official title: Prospective Multicenter Registry On Radiation Dose Estimates of Cardiac CT Angiography in Daily Practice in 2017 (PROTECTION VI)
Background:
CCTA is a common way to evaluate coronary artery disease. It stands for coronary computed tomography angiography. It uses scanning to look at the arteries that supply blood to the heart. It is noninvasive, widely available, and generally accurate. But it does expose people to radiation. Exposure to high amounts of radiation can increase a person s risk of getting cancer. Researchers want to learn more about the relationship between CCTA and radiation exposure.
Read more
Objective:
To see how much radiation is used to take pictures of the heart and how measures to reduce radiation are used around the world.
Eligibility:
People ages 18 years and older who need a computed tomography (CT) scan of the heart
Design:
Participants will be screened with a review of their medical records.
Participants may have a pregnancy test.
Participants will have the scheduled scan. Small, sticky discs will be placed on the chest. A small tube will be placed into a vein in the arm. A contrast material (dye) will be given through it. Participants will lie on the CT scanning table.
A CCTA scan usually takes about 15 minutes if the heart rate is slow and steady.
Read the detailed description
Cardiac CT angiography is a commonly used test to take detailed pictures of the heart to diagnose heart disease; however, it is associated with radiation exposure. Several technological advances in both scanner hardware and software are now available to reduce the radiation exposure to patients. The purpose of this study is to evaluate the worldwide usage of these radiation dose saving strategies in daily practice and analyze their effect on image quality.
- Conditions
- Coronary Artery Disease, Coronary Disease, Myocardial Ischemia, Arterial Occlusive Diseases, Arteriosclerosis
- Keywords
- Cardiac Computed Tomography, Radiation, Iterative Reconstruction, Natural History
- Medical subject headings
- Coronary Artery Disease, Coronary Disease, Myocardial Ischemia, Arterial Occlusive Diseases, Arteriosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | People ages 18 years and older who need a computed tomography (CT) scan of the heart. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine radiation dose estimates of cardiac CT angiographies in daily practice
We will assess the variation of radiation dose with respect to vendors, CT systems and study sites. Furthermore, we will evaluate the usage of dose saving strategies including the abovementionedin daily practice and analyze their effect on diagnostic image quality. On the basis of the collected data, we will evaluate the potential use of additional dose savings for each individual site.
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2017
- Study start3 Oct 2017
- Primary completion30 Jun 2018
- Study completion11 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Marcus Y Chen, M.D., Principal investigator, National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03253692
- Sponsor's protocol ID
- 170146
- Other IDs
- 17-H-0146
- Status last verified
- 6 Apr 2026
- First submitted
- 17 Aug 2017
- Last updated
- 17 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Registry On Radiation Dose Estimates of Cardiac CT Angiography in Daily Practice in 2017 (PROTECTION VI)
- ClinicalTrials.gov ID
- NCT03253692
- Acronym / sponsor ID
- 170146
- Conditions
- Coronary Artery Disease, Coronary Disease, Myocardial Ischemia, Arterial Occlusive Diseases, Arteriosclerosis
- Keywords
- Cardiac Computed Tomography, Radiation, Iterative Reconstruction, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 3 Oct 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 11 Oct 2018 (actual)
- First posted
- 18 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
CCTA is a common way to evaluate coronary artery disease. It stands for coronary computed tomography angiography. It uses scanning to look at the arteries that supply blood to the heart. It is noninvasive, widely available, and generally accurate. But it does expose people to radiation. Exposure to high amounts of radiation can increase a person s risk of getting cancer. Researchers want to learn more about the relationship between CCTA and radiation exposure.
Objective:
To see how much radiation is used to take pictures of the heart and how measures to reduce radiation are used around the world.
Eligibility:
People ages 18 years and older who need a computed tomography (CT) scan of the heart
Design:
Participants will be screened with a review of their medical records.
Participants may have a pregnancy test.
Participants will have the scheduled scan. Small, sticky discs will be placed on the chest. A small tube will be placed into a vein in the arm. A contrast material (dye) will be given through it. Participants will lie on the CT scanning table.
A CCTA scan usually takes about 15 minutes if the heart rate is slow and steady.
Detailed description
Cardiac CT angiography is a commonly used test to take detailed pictures of the heart to diagnose heart disease; however, it is associated with radiation exposure. Several technological advances in both scanner hardware and software are now available to reduce the radiation exposure to patients. The purpose of this study is to evaluate the worldwide usage of these radiation dose saving strategies in daily practice and analyze their effect on image quality.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –People ages 18 years and older who need a computed tomography (CT) scan of the heart. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Data confirming the inclusion/exclusion criteria will be confirmed at the study visit. Overall, up to 100 subjects will be enrolled locally at the NIH. A member of the study team will review the CT procedures and confirm that the participants do not have any serious health problems or concomitant conditions or medications that would prevent them from having the CT. A member of the study team will perform a pregnancy test (if applicable) in female participants of childbearing potential. If you are nursing, you will be excluded from this study. All tests will follow NIH Clinical Center policies and clinical consent forms for individual tests may be obtained in addition to the study protocol consent as applicable. Sites outside the NIH will use similar standard of care procedures for cardiac CT eligibility.
Key inclusion criteria (3 listed)
Key exclusion criteria (1 listed)
- 1) Female participants who are pregnant or nursing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determine radiation dose estimates of cardiac CT angiographies in daily practice
Time frame: day 0
We will assess the variation of radiation dose with respect to vendors, CT systems and study sites. Furthermore, we will evaluate the usage of dose saving strategies including the abovementionedin daily practice and analyze their effect on diagnostic image quality. On the basis of the collected data, we will evaluate the potential use of additional dose savings for each individual site.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
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.
Marcus Y Chen, M.D. principal investigator
National Heart, Lung, and Blood Institute (NHLBI)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Coronary Disease, run by National Heart, Lung, and Blood Institute (NHLBI) at 3 sites in United States.
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 3 inclusion and 1 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 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Determine radiation dose estimates of cardiac CT angiographies in daily practice (time frame: day 0). 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 17 Aug 2026.