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New ultrasound tool could spare heart attack patients a second procedure

NCT ID NCT07264881

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 is testing a new tool called UFR, which uses ultrasound images to measure blockages in heart arteries during a heart attack. Currently, the most accurate method requires patients to return 30 days later for a second invasive procedure. The study will enroll 200 heart attack patients and follow them for one year to see if UFR can provide reliable measurements right away, potentially saving patients from an extra procedure.

What this could mean

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

Active substance
IVUS-based Fractional Flow Reserve (UFR) - a diagnostic test using ultrasound images to measure blockages
What this could lead to
If successful, this could allow doctors to assess all blockages during the initial heart attack procedure, eliminating the need for a second invasive test 30 days later.
What could go wrong
This is an early-stage study with only 200 participants, so results may not apply to everyone. The new tool might not be accurate enough to replace the current gold standard.

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 200 people

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

Expected to start

Dec 2025

An estimate. Start dates often move.

Expected to finish

Jun 2028

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 will be sourced from patients presenting with Acute Coronary Syndrome (STEMI or High-Risk NSTEMI) to the Emergency Department and/or cardiology services of participating multi-center hospitals. Eligible participants will be identified and screened for enrollment in the Cardiac Catheterization Laboratory (Cath Lab) immediately following their successful index PCI procedure (T0).

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, any sex. * The participant is able to understand the study procedures and provides voluntary written informed consent. * Diagnosed with Acute Coronary Syndrome (ACS) and meets the criteria for one of the two pre-specified cohorts: * STEMI Cohort: Symptom onset \< 12 hours with ECG findings of ST-segment elevation myocardial infarction. * High-Risk NSTEMI Cohort: Meets at least one of the following: GRACE score \> 140, dynamic ECG changes (ST-T), or significant Troponin elevation. * Has undergone successful emergency PCI of the Culprit Vessel (CV), with post-PCI TIMI flow Grade 3. * Coronary angiography confirms Multi-vessel Disease (MVD), defined as: at least one Non-Culprit Vessel (NCV) with a moderate stenosis (visual diameter stenosis 50-90%). * The target NCV (50-90% stenosis) is deemed by the investigator to be anatomically suitable for IVUS and pressure-wire assessment. * The participant agrees and is confirmed to be willing and able to strictly adhere to the protocol and complete all required invasive procedures, CMR scans, and follow-ups at the four timepoints (T0, T-CMR, T1, T2). Exclusion Criteria: * Presence of cardiogenic shock on presentation, or persistent hemodynamic instability despite successful PCI of the culprit vessel. * Known severe allergy to iodinated contrast media or gadolinium-based contrast agents (used for CMR). * Female participants who are pregnant, breastfeeding, or planning pregnancy within the 1-year study period.Unprotected left main coronary artery disease (stenosis \<50%) requiring intervention. * Prior history of Coronary Artery Bypass Grafting (CABG) surgery.The target NCV has received prior PCI (e.g., existing stent) or surgical revascularization. * The target NCV is a Chronic Total Occlusion (CTO). * Severe renal insufficiency (eGFR \< 30 ml/min/1.73m²) or currently undergoing chronic dialysis. * Standard contraindications to CMR examination (e.g., claustrophobia, non-MRI-compatible metallic implants/pacemakers). * Known presence of a severe non-cardiac comorbidity with an expected lifespan of \< 12 months (e.g., advanced malignancy). * Known severe hematological disease (e.g., severe anemia, active bleeding, thrombocytopenia \< 70 x 10⁹/L) rendering the participant unsuitable for multiple invasive procedures. * Inability to provide informed consent or comply with the complex longitudinal follow-up protocol due to psychiatric, cognitive, or other reasons. * Currently participating in another interventional (drug or device) clinical study. * Any other condition which, in the investigator's opinion, makes the participant unsuitable for enrollment (e.g., severe valvular heart disease, cardiomyopathy).

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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.

How to take part

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

  1. The places running it

    1 site. 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

  • Beijing Anzhen Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100029, China

More trials for these conditions

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