AI reads heart scans to guide treatment in 20,000 patients
NCT ID NCT06376851
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This registry is collecting data from 20,000 people with coronary artery disease to see if an AI tool that analyzes CT scans of the heart can help doctors make better treatment decisions. The AI measures the amount and type of plaque in the arteries. Researchers will compare how medical management changes after doctors get the AI results versus standard CT scans alone. This is an observational study, so no new treatment is being tested.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AI-enabled quantitative coronary plaque analysis (AI-QCPA)
- What this could lead to
- If successful, this could show that AI analysis of CT scans helps doctors choose better treatments for heart disease patients.
- What could go wrong
- This is an observational registry, not a treatment trial, so it won't prove that AI analysis directly improves health outcomes. Results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
About 20,000 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2024
- Expected to finish
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Mar 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Deidentified data will be collected for all patients who have had a CCTA with plaque detected or a stress test and are included by the site in the registry.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria (all must be present) : 1. Groups 1, 2,4,5 and 6: CCTA and plaque detected 2. Group 3: Any patient with a stress test (stress echocardiogram or nuclear imaging including SPECT or PET) and no CCTA within the 90 days prior to site activation 3. Groups 1,2,3 and 4: Clinically stable, symptomatic 4. Group 6: Clinically stable without symptoms suggestive of CAD at the time of the CCTA Exclusion Criteria (all must be absent) : 1. ED presentation (at the time of the CCTA or stress test) 2. Groups 1,2,3,4, and 6: Previous history of CAD (prior to the CCTA or stress test with history of revascularization) 3. Group 5: Prior history of PCI in multiple vessel territories, PCI in the Left Main, CABG, and/or any other conditions or limitations which would prevent successful CCTA processing by HeartFlow 4. Acute chest pain (in patients who have not been ruled out for ACS) 5. Previously evaluated with and/or in a study which includes AI-QCPA
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Moses Cone Memorial Hospital
Greensboro, North Carolina, 27401, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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