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New imaging method could replace risky heart wire test

NCT ID NCT07613996

Diagnosis Sponsor: Shanghai Zhongshan Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether a new software-based method called Angio-IMR can diagnose coronary microvascular disease (blockages in tiny heart arteries) as accurately as the current standard test that uses a pressure wire inside the artery. About 192 adults with stable chest pain or suspected heart disease will have their standard angiogram images analyzed by five different software programs under three conditions (rest, mild drug effect, and strong drug effect). The goal is to see which software and condition best matches the wire-based results, potentially offering a safer, wire-free alternative.

What this could mean

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

Active substance
Angiography-derived Index of Microcirculatory Resistance (Angio-IMR) — a software-based diagnostic test using standard X-ray images
What this could lead to
If successful, this could provide a safer, simpler way to diagnose coronary microvascular disease without needing a pressure wire inside the heart arteries.
What could go wrong
This is an observational study, not a treatment trial. The new method may not match the accuracy of the wire-based test, and results may vary across different software versions.

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 192 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Who is studied

The study population consists of adult patients (aged 18 and older) clinically diagnosed with stable angina or suspected coronary artery disease who are scheduled to undergo conventional coronary angiography and invasive physiological assessment. Participants are prospectively and consecutively recruited from multiple clinical centers in China. The population specifically targets individuals with non-obstructive coronary arteries (stenosis \< 50%) or those with moderate stenosis (50%-90%) but preserved epicardial flow (FFR \> 0.80), where assessment of coronary microvascular function is clinically indicated to investigate the cause of ischemia.

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: * Stable angina or suspected coronary heart disease. * Scheduled for coronary angiography and physiological assessment. * Target vessel with stenosis \< 50% or 50%-90% with fractional flow reserve (FFR) \> 0.80. * Provided informed consent. Exclusion Criteria: * Hemodynamic instability (acute myocardial infarction, cardiogenic shock, severe arrhythmia). * Contraindications to angiography (e.g., end-stage renal disease). * Contraindications to adenosine (e.g., severe asthma, high-degree atrial-ventricular block). * Life expectancy \< 1 year or pregnancy. * Target vessel unsuitable for wire operation (left main lesion, severe tortuosity) or stenosis \> 90%.

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Conditions

The condition(s) this trial relates to.

coronary artery disorder coronary microvascular disorder

As listed by the trial registrant

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

Coronary artery disease Microvascular coronary artery disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The First Affiliated Hospital, Sun Yat-sen University

    RECRUITING

    Guangzhou, China

  • Zhongshan Hospital, Fudan University

    RECRUITING

    Shanghai, Please Select, 200000, China

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