New ultrasound tool could spare heart attack patients a second procedure
NCT ID NCT07264881
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
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2025
An estimate. Start dates often move.
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, 100029, China
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