NHLBI-Emory Advanced Cardiac CT Reconstruction
Structural Heart Disease
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Observational
- Phase
- Not applicable / not listed
- Age range
- 18 years - 100 years
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 1000 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Read the full description
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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
- INCLUSION CRITERIA:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
1. Male or female, aged \>= 18 years
2. Undergoing clinically-indicated contrast-enhanced time-resolved cardiac CT for structural heart disease.
3. Ability of subject to understand and the willingness to sign a written informed consent document.
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this study:
1. Unable to complete contrast-enhanced cardiac CT acquisition for any reason
2. Unwilling to authorize future use of their imaging data for research
Study population
Adults undergoing clinically-indicated contrast-enhanced time-resolved cardiac CT for suspected structural heart disease
Understand screeningTreatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not reported
- Masking
- Not reported
1
Adults undergoing clinically-indicated contrast-enhanced time-resolved cardiac CT for suspected structural heart disease
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
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.
Time frame: 5 years
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.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (2)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
2 locations
Emory University Midtown HospitalAtlanta, Georgia, United StatesStatus unknown
National Institutes of Health Clinical CenterBethesda, Maryland, United StatesStatus unknown
Study team and timeline
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Nov 15, 2026 Estimated
- Primary completion
- Jan 30, 2032 Estimated
- Study completion
- Jan 30, 2032 Estimated
- First posted
- May 13, 2022 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study title
NHLBI-Emory Advanced Cardiac CT Reconstruction
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 11, 2026 · Last registry update: Nov 10, 2026