NHLBI-Emory Advanced Cardiac CT Reconstruction

NCT05372627 | Not Yet Recruiting

• 2 other identifiers: 10000556000556-H
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Structural Heart Disease

Keywords

Heart Disease; Image; Natural History

Outcome Measures

Primary Outcomes (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.

  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.

  5 years

Study Arms (1)

1

Adults undergoing clinically-indicated contrast-enhanced time-resolved cardiac CT for suspected structural heart disease

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults undergoing clinically-indicated contrast-enhanced time-resolved cardiac CT for suspected structural heart disease

You may qualify if:

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• Male or female, aged \>= 18 years
• Undergoing clinically-indicated contrast-enhanced time-resolved cardiac CT for structural heart disease.
• Ability of subject to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Unable to complete contrast-enhanced cardiac CT acquisition for any reason
• Unwilling to authorize future use of their imaging data for research

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (2)

Emory University Midtown Hospital

Atlanta, Georgia, 30308, United States

Location

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Marcus Y Chen, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Margaret C Lowery, R.N.

CONTACT

(301) 451-3128; peg.lowery@nih.gov

Marcus Y Chen, M.D.

CONTACT

(301) 496-0077; chenmy@mail.nih.gov

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 13, 2022
• Study Start (Estimated): May 12, 2026
• Primary Completion (Estimated): January 30, 2031
• Study Completion (Estimated): January 30, 2031
• Last Updated: May 7, 2026

Record last verified: 2025-12-02

Locations

US (2)