An observational study in Structural Heart Disease, sponsored by National Heart, Lung, and Blood Institute (NHLBI). Not yet recruiting at 2 sites in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by National Heart, Lung, and Blood Institute (NHLBI) · Observational
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.
Study Description:
This is an observational technical development study of advanced mathematical image reconstruction of raw CT data on patients with structural heart disease, in order to create better pictures.
The raw CT data are obtained in the course of clinically-indicated contrast-enhanced time-resolved cardiac CT without any change in clinical practice. The raw data are acquired on a specific imaging system (Canon Aquilion One) at the enrolling site(s).
Subjects are recruited among candidates selected clinically to undergo time-resolved cardiac CT in the diagnosis and treatment of structural heart disease. After consenting in writing, data are abstracted from their medical record, and the raw CT data used for standard medical care are copied. There is no investigational component to the standard clinical CT data acquisition and there is no change in radiation exposure from standard clinical CT examination. Subject participation concludes at the end of the standard clinical CT examination.
The raw CT data are sent with PII to NHLBI investigators who will remove identifiers and replace with a code before transmitting the image to the industry collaborator (Canon) for investigational advanced mathematical image reconstruction. The reconstructed CT images are then transmitted back to the NHLBI where the images are re-identified. The NHLBI investigators will then forward the reconstructed image to the site investigators. The advanced image reconstruction may be performed at NHLBI once adequate computer resources are available.
The research analysis consists of a comparison of standard CT images from the enrolling site with the advanced mathematical image reconstructions ("investigational images") for quality metrics.
The investigational advanced mathematical image reconstruction kernel may be changed iteratively for the purpose of technical development during this study.
The advanced image reconstruction is considered investigational because it is a commercial device not yet cleared for marketing by the US Food and Drug Administration. The advanced image reconstruction yields images with four-fold higher spatial resolution that standard images, based on the same standard CT acquisition. The advanced reconstruction images are labeled investigational and offer potential benefit to research subjects who are also patients. Therefore, the images are labeled investigational and returned to the local physician-investigators, to use at their discretion. This includes the possibility of informing medical decision-making based on investigational higher-resolution images.
Objectives:
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.
Endpoints:
The primary endpoint is a semi-quantitative measure of superiority of advanced mathematical image reconstruction compared with standard cardiac CT image reconstruction for study-specific fine detail.
Secondary endpoints include quantitative signal-to-noise (SNR), contrast-to-noise (CNR), and image noise.
Exploratory endpoints include Likert-type scales of image noise, artifacts, subjective image contrast, image sharpness, and diagnostic confidence.
2,135 studies on the registry are indexed under Heart Diseases; 252 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 350 across 592 observational studies indexed under Heart Diseases.
Browse Heart Diseases studies →National Heart, Lung, and Blood Institute (NHLBI) is the lead sponsor of 1,143 studies on the registry; 71 are open to participants now.
Of its 58 completed or terminated interventional studies of FDA-regulated products, 51 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adults undergoing clinically-indicated contrast-enhanced time-resolved cardiac CT for suspected structural heart disease
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adults undergoing clinically-indicated contrast-enhanced time-resolved cardiac CT for suspected structural heart disease
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.
The primary endpoint is a semi-quantitative measure of superiority of advanced mathematical image reconstruction compared with standard cardiac CT image reconstruction for study-specific fine detail. Specifically, the endpoint is a Likert-like scale assessing visibility of small structures or fine detail.
Time frame: 5 years
Plan to share: Undecided
Start is estimated for Nov 2026; primary completion for Jan 2032, 62 months later.
Of 184 non-industry observational studies under Heart Diseases, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 118. This study's planned 62 months is above that.
Counting every sponsor, half of 238 studies reached it within 45 months; a quarter within 18 and three quarters within 95.
Start moved 32 times since we started tracking on Sep 25, 2026: Sep 2026 → Nov 2026, last on Nov 10, 2026.
Primary completion moved once since we started tracking on Sep 25, 2026: Jan 2031 → Jan 2032, on Nov 3, 2026.
Completion moved once since we started tracking on Sep 25, 2026: Jan 2031 → Jan 2032, on Nov 3, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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