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New algorithm could spot dangerous heart blockages without extra procedures

NCT ID NCT07551518

Knowledge-focused Sponsor: China National Center for Cardiovascular Diseases Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at data from 100 patients who had heart artery imaging and pressure measurements. Researchers developed a new computer algorithm to analyze ultrasound images of the arteries and estimate how much they block blood flow. The goal was to see if the algorithm could accurately identify significant blockages without needing an additional invasive pressure wire. This was a retrospective analysis, meaning no new treatments or procedures were given to patients.

What this could mean

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

What this could lead to
If successful, this algorithm could help doctors assess heart blockages more accurately using ultrasound images, potentially reducing the need for invasive pressure wire measurements.
What could go wrong
This is a small, retrospective study using existing data, not a prospective trial. The algorithm may not perform as well in broader, real-world settings or 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

100 people

The number who actually took part.

Started

Dec 2024

Finished

May 2025

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

This retrospective study includes approximately 100 adult patients with suspected or known coronary artery disease who underwent clinically indicated invasive coronary angiography, intravascular ultrasound (IVUS) imaging, and fractional flow reserve (FFR) measurement at Fuwai Hospital. The cohort consists of patients with intermediate coronary lesions (30-90% diameter stenosis by visual estimation) for whom both anatomical assessment by IVUS and physiological assessment by FFR were deemed clinically necessary. Data were collected from existing medical records and imaging archives, and all personal identifiers have been removed prior to analysis.

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 * Age ≥18 years. * Underwent clinically indicated coronary angiography, intravascular ultrasound (IVUS) imaging, and invasive fractional flow reserve (FFR) measurement at Fuwai Hospital. * IVUS pullback imaging of sufficient quality for analysis, covering the entire lesion segment of interest. * Valid FFR measurement recorded. * Presence of at least one native coronary artery stenosis with visual diameter stenosis between 30% and 90%. Exclusion Criteria * Chronic total occlusion (CTO) of the target vessel. * Prior coronary artery bypass grafting (CABG) involving the target vessel. * IVUS pullback did not cover the entire lesion. * Severe myocardial bridge or vessel spasm in the interrogated vessel. * Substantial thrombosis or dissection identified by IVUS. * Image quality deemed inadequate for analysis by two independent analysts.

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Conditions

The condition(s) this trial relates to.

coronary artery disorder coronary stenosis

As listed by the trial registrant

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

Algorithm validation for fractional flow reserve derived from intravascular ultrasound Coronary artery disease Coronary stenosis

Contacts and locations

Locations

  • Fuwai hospital

    Beijing, Select, 100037, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.