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AI software may replace invasive heart tests — a validation study puts it to the test

NCT ID NCT07763769

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time

Summary

This study tests whether a software tool called AutocathFFR can accurately measure the severity of coronary artery blockages from standard 2D angiogram images, compared to the gold-standard invasive FFR measurement. The software uses machine learning to analyze images taken during cardiac catheterization, potentially avoiding the need for a pressure wire. Researchers will evaluate its sensitivity and specificity in adults with stable or unstable angina or NSTEMI who underwent both procedures. If the software proves accurate, it could offer a less invasive way to guide treatment decisions.

What this could mean

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

Active substance
MedHub AutocathFFR, a software device that analyzes standard 2D coronary angiogram images using machine learning to estimate fractional flow reserve (FFR)
What this could lead to
If validated, this software could let doctors assess coronary artery disease severity without invasive pressure-wire measurements, making diagnosis faster and less risky.
What could go wrong
This is an observational validation study, not a treatment trial. The software's accuracy may not meet the performance goals, and results may not generalize beyond the studied population.

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

277 people

The number who actually took part.

Started

Nov 2025

Finished

Jun 2026

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

Angiograms from adult subjects with stable angina, unstable angina or NSTEMI who underwent a clinically indicated invasive coronary angiography and on whom invasive FFR has been measured to assess the hemodynamic significance of suspected coronary lesions.

Ages

23 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: * Age \> 22 years * Subjects with stable angina pectoris, unstable angina pectoris, or NSTEMI and in whom invasive FFR was performed to assess a non-culprit stenosis in at least one coronary artery * Subject underwent a clinically indicated Invasive Coronary Angiogram (ICA) * Subject underwent invasive FFR with intravenous (IV) or intracoronary adenosine, or adenosine triphosphate (ATP), as hyperemic stimulus Exclusion Criteria: * Angiogram not obtained on a United States Food and Drug Administration (FDA)-cleared C-arm angiography system * Invasive FFR not obtained on an FDA-cleared FFR catheter tip pressure transducer (also known as a pressure wire) * Vessel size less than 2 mm * Subject presents with an ST-elevation myocardial infarction (STEMI) * Chronic total occlusion (CTO) in target vessel * Prior coronary artery bypass graft (CABG) surgery, heart transplant or valve surgery, prior transcatheter aortic valve implantation/replacement (TAVI/TAVR), or severe left-sided valvular disease * Known left ventricular ejection fraction (LVEF) ≤ 30% * Arteries supplying akinetic or severe hypokinetic territories on target lesion, if already known based on prior imaging * Thrombolysis in Myocardial Infarction (TIMI) flow grade equal to or lower than 2 at baseline * Target lesion involves Left Main (stenosis \>50%) * Percutaneous coronary intervention (PCI) with stent in target vessel in past 12 months, or target vessel involves in-stent restenosis * Target coronary vessel provides collaterals to a chronically occluded vessel * Coronary angiography was not performed per standard of care at a cine frame rate of at least 7 frames per second * Presence of aortic damping * Distortion of the waveform * Less than two different angiographic views for each lesion of interest in the Left Circumflex Artery (LCX), Left Anterior Descending Artery (LAD), or Right Coronary Artery (RCA) * Lesion is not clearly visible

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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

  • Emory University Hospital

    Atlanta, Georgia, 30322, United States

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010, United States

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501, United States

  • University of Virginia Health System

    Charlottesville, Virginia, 22908, United States

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