Study of New Low-Radiation CT Imaging Methods for Heart and Blood Vessel Disease
Using Advanced Cardiac CT Angiography to Detect and Monitor Coronary Disease
Led by National Heart, Lung, and Blood Institute (NHLBI) · Updated on 2026-08-03
5000
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating new radiation techniques for cardiac CT angiography to reduce radiation exposure while maintaining accuracy in imaging the heart and blood vessels. The study focuses on whether these low-dose imaging methods can accurately predict patient outcomes and monitor the progression of coronary artery disease. It also assesses updated cardiac imaging software and artificial intelligence tools compared to standard images.
Participants will undergo cardiac CT scans using the Cannon Aquilion ONE CT system, which employs low-radiation dose methods for coronary angiography. The study involves a single group of adults with a clinical indication for coronary CT angiography. Scans may include the use of a contrast agent and can last up to two hours. Follow-up contacts, including telephone or office visits, may occur depending on initial scan results to check for further cardiovascular testing or events.
During the study, participants have physical exams, medical history reviews, and blood tests to check kidney function before imaging. Researchers will compare cardiovascular events in participants based on coronary artery stenosis levels and evaluate the quality and diagnostic accuracy of new CT technologies against standard methods. The study includes ongoing monitoring for clinical events and radiation dose comparisons. Participation may last several years until the study completion date in 2027.
CONDITIONS
Brief Title
Evaluating New Radiation Techniques for Cardiovascular Imaging
Research Team
M
Margaret C Lowery, R.N.
M
Marcus Y Chen, M.D.
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This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
Factors
Low-Radiation Cardiac CT (Investigational)
Current Diagnostic Pathway
What it is
Non-invasive cardiac CT angiography using a low-radiation protocol on the Canon Aquilion ONE scanner to visualize coronary arteries.
Diagnostic assessment for suspected coronary artery disease using invasive coronary angiography or stress perfusion MRI to directly detect stenosis or perfusion defects.
Primary use or purpose
Evaluation of coronary artery stenosis and stratification of patient risk for adverse cardiac events using a non-invasive, lower-radiation CT approach.
Definitive diagnosis of significant coronary artery narrowing and assessment of patient risk, providing a gold standard for disease confirmation.
How it is performed
Participants undergo a cardiac CT scan with reduced radiation dose, using iterative reconstruction techniques and intravenous contrast when required.
Undergo invasive coronary angiography involving catheter insertion into the coronary arteries, or a non-invasive MRI with stress agents; both are performed in specialized cardiac centers.
Evidence status
Clinical effectiveness is under investigation. No published primary outcome results are available yet from this ongoing trial.
Extensive published evidence confirms invasive coronary angiography and stress perfusion MRI provide accurate assessment of coronary stenosis and patient risk.
Important limitations
As a novel protocol, the method’s diagnostic accuracy, risk prediction, and image quality in broader clinical use remain to be established. Potential limitations include image artifacts, technical variability, and reduced performance in heavily calcified vessels or arrhythmias.
Invasive angiography carries procedural risks, requires hospitalization, and is not suitable for all patients. MRI may not be available or tolerated in some cases due to device implants or claustrophobia.
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
Who Can Participate
Age: 18Years - 100Years
All Genders
Eligibility Criteria
You may qualify if you...
Clinical indication for a coronary CT angiography exam
Age equal to or greater than 18 years
Able to understand and willing to sign the Informed Consent Form
Able and willing to provide follow-up information
You will not qualify if you...
Pregnancy
Severe renal excretory dysfunction with estimated glomerular filtration rate below 30 mL/min/1.73m2 if receiving intravenous contrast
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Imaging and Evaluation
Duration - Single session
Participants undergo physical exams, medical history review, blood tests, and a cardiac CT scan that may include contrast. The scanning session can last up to 2 hours.
1 visit (in-person)
Follow-up
Duration - Varies by participant
Follow-up contacts by telephone or office visits may occur based on initial scan results to monitor heart health and any further cardiovascular testing.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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Published Research Related To This Trial
Prospective evaluation of the influence of iterative reconstruction on the reproducibility of coronary calcium quantification in reduced radiation dose 320 detector row CT.