Background:
Doctors use computed tomography (CT) to get detailed pictures of the heart. CT uses x-rays to gather raw data. Computers assemble this data to make the images doctors look at. A new computer technique can make higher resolution images from the same CT scans. In this natural history study, researchers will take normal CT images of the heart. They will compare those images to super high-resolution (super high-res) images made with a super-computer.
Objective:
To improve the quality of heart CT scans by using new methods to create the images.
Eligibility:
People aged 18 years or older who need a CT scan for heart disease.
Design:
Participants will have a normal CT scan. A substance will be injected through a tube in their arm. They will lie on a table in a large, donut-shaped machine. An X-ray tube will move around their body, taking many pictures.
Researchers will use the normal CT scans to create super high-res images. They may do this at the NIH. They may also send the images to the company that made the CT scanner. Participants personal information will be removed before images are sent to the company. The personal information will be replaced by a code.
The super high-res images will be returned to the NIH.
Some information will be collected from participants medical records. Researchers will compare the normal scans to the super high-res images.
Participants' own doctors will also have a chance to see the super high-res images.
Participants' CT pictures will be stored and used for future NIH research.
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
. Ability of subject to understand and the willingness to sign a written informed consent document.
Exclusion criteria
. Unable to complete contrast-enhanced cardiac CT acquisition for any reason
. Unwilling to authorize future use of their imaging data for research
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing a new way to reconstruct CT scan images rather than a new drug or procedure — does that mean the main risk is just the CT scan itself, and are there any additional risks I should know about?
2Since this trial is listed as 'not yet recruiting,' how long might it be before it actually opens, and would waiting to potentially join it delay any other imaging or treatment decisions I need to make now for my structural heart disease?
3The trial is comparing advanced mathematical image reconstruction against the standard method — if the new approach turns out to produce better images, would that actually change the treatment plan for someone in my situation, or is this more about improving future patients' care?
4This study doesn't have a traditional phase number, which suggests it may be more of a diagnostic or technical study rather than a treatment trial — can you help me understand whether joining this would be separate from, or connected to, whatever treatment path we're already considering for my heart condition?
5Are there specific types or severities of structural heart disease this trial is designed for, and based on my diagnosis, is this even a study worth keeping on my radar as a potential option to discuss once it opens?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The objective of this research protocol is to determine whether advanced mathematical image reconstructions create superior images compared with standard cardiac CT image reconstruction in patients with structural heart disease.
Timeframe: 5 years
Trial details
NCT IDNCT05372627
SponsorNational Heart, Lung, and Blood Institute (NHLBI)