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AI heart scan software aims to spot dangerous blockages without invasive probes

NCT ID NCT06018194

Diagnosis Sponsor: Elucid Bioimaging Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time

Summary

This study tests whether a software program called ElucidVivo can accurately predict blood flow blockages in the heart using images from a standard CT scan. The software analyzes plaque buildup in the coronary arteries to estimate a value called FFRct, which indicates how much a blockage restricts blood flow. Researchers compare the software's estimates to the actual invasive FFR measurements taken during a catheter procedure in adults with coronary artery disease. If the software proves reliable, it might offer a less invasive way to diagnose significant blockages.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ElucidVivo, a software that analyzes coronary CT scans to estimate blood flow blockage
What this could lead to
If accurate, this software could help doctors identify significant coronary artery blockages from a CT scan, potentially reducing the need for invasive catheter procedures.
What could go wrong
The trial is testing diagnostic accuracy, not treatment outcomes. The software may not match the precision of invasive FFR, and results may vary across different patient groups.

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

439 people

The number who actually took part.

Started

Sep 2023

Finished

Jul 2025

Lead sponsor

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

Adults \>18 years with CCTA (\>64-detector row) performed within 60 days of undergoing invasive FFR.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria 1\. Adults \>18 years with CCTA (\>64-detector row) performed within 60 days of undergoing invasive FFR. Exclusion Criteria 1. History of coronary revascularization with coronary artery bypass graft (CABG) surgery and/or percutaneous coronary intervention (PCI) (stent or balloon angioplasty) prior to CCTA and invasive FFR. 2. History of myocardial infarction prior to CCTA and invasive FFR. 3. Known complex congenital heart disease. 4. Existing pacemaker or internal defibrillator lead implantation(s). 5. Existing prosthetic heart valve. 6. Absence of CCTA Digital Imaging and Communications in Medicine (DICOM) data for analysis. 7. Absence of invasive coronary angiography imaging or adequate description defining the position of the invasive FFR wire location. 8. Poor CCTA image quality that does not meet Elucid image processing requirements for plaque and FFRct (See Image Analysis Manual below). 9. Absence of study date for CCTA or invasive FFR. 10. Interval clinical myocardial infarction, diagnosis of decompensated heart failure, stroke, or coronary revascularization procedure between CCTA and invasive FFR. 11. Non-diagnostic CCTA or invasive FFR. Studies where the results of the study were deemed non-diagnostic for clinical decision-making were excluded. 12. CCTA or invasive FFR studies performed prior to 1 January 2012. 13. Subjects who had IFR or CFR and not measured FFR.

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Conditions

The condition(s) this trial relates to.

coronary artery disorder Plaque, Amyloid

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Coronary artery disease

Contacts and locations

Locations

  • Ascension Medical Group

    Nashville, Tennessee, 37205, United States

  • Cardiovascular Medical Group of Southern California

    Beverly Hills, California, 90210, United States

  • Midwest Heart and Vascular Specialists

    Overland Park, Kansas, 66211, United States

  • Parkview Health

    Fort Wayne, Indiana, 46845, United States

  • Piedmont Healthcare

    Atlanta, Georgia, 30309, United States

  • University of Virginia

    Charlottesville, Virginia, 22908, United States

  • Valley Health System

    Ridgewood, New Jersey, 07450, United States

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