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For Patients With Myocardial Infarction and Multiple Vessel: Testing if Ultrasound (UFR) Can Guide All Needed Treatment in One Procedure, Avoiding a Return Hospital Visit for a Second Operation.

NCT07264881 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2025-12-04

No results posted yet for this study

Summary

Brief Summary The Purpose of the Study : The purpose of this study is to find a safe and reliable "one-stop" solution for treating heart attack patients who have multiple blocked arteries. Currently, doctors face a dilemma: Testing these other blockages during the heart attack procedure is often unreliable.

The most accurate method requires asking the patient to return 30 days later for a second invasive procedure, which is a significant burden.

The Study's Hypothesis : We are testing a new tool called UFR, which uses ultrasound images to measure blockages. Our hypothesis (or "educated guess") is that this new UFR tool is not affected by the body's stress during a heart attack and can provide a true, reliable measurement right away.

The Question the Study is Trying to Answer ： The main question this study is trying to answer is: Can the new "one-stop" UFR tool, used during the initial heart attack procedure, accurately predict which blockages are truly serious... thereby eliminating the need for patients to return for a second procedure 30 days later? Researchers will also follow 200 patients for one year, using advanced scans (like UFR, standard tests, and MRI), to better understand how the heart and arteries heal and change over time.

Conditions

  • Microvascular Obstruction (MVO)
  • Multivessel Coronary Artery Disease
  • ACS (Acute Coronary Syndrome)
  • ST Elevation Myocardial Infarction (STEMI)

Interventions

DIAGNOSTIC_TEST

IVUS-based Fractional Flow Reserve (UFR)

UFR is a "virtual" fractional flow reserve calculated from Intravascular Ultrasound (IVUS) images using computational fluid dynamics. In this study, it is calculated from IVUS runs of the Non-Culprit Vessel (NCV) performed at the T0 (Acute) procedure. This T0 UFR value is the primary diagnostic test being evaluated against the T1 (30-day) pFFR gold standard. UFR will also be assessed at the T2 (1-year) follow-up.

DIAGNOSTIC_TEST

Invasive Coronary Physiology Measurement (FFR/RFR/IMR)

Invasive physiological measurements are performed using a standard pressure-sensing guidewire.T0 (Acute): FFR, RFR, and IMR are measured in the Non-Culprit Vessel (NCV) and the post-PCI Culprit Vessel (CV).T1 (30-Day): FFR and RFR are measured in the NCV. This T1 pFFR (threshold\< 0.80) serves as the gold standard comparator for the primary endpoint.T2 (1-Year): FFR is reassessed in the CV and any untreated NCV.

DIAGNOSTIC_TEST

Cardiac Magnetic Resonance (CMR)

The scan is performed prior to discharge to quantify myocardial injury, including infarct size, Left Ventricular Ejection Fraction (LVEF), and the extent of Microvascular Obstruction (MVO). CMR data serves as the "tissue" component for the secondary 'structure-function-tissue' coupling analysis.

Sponsors & Collaborators

  • Beijing Anzhen Hospital

    lead OTHER

Principal Investigators

  • Hai Gao, MD, PHD · Beijing Anzhen Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-02
Primary Completion
2027-06-22
Completion
2028-06-22
FDA Device
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07264881 on ClinicalTrials.gov