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NOT YET RECRUITING
NCT07264881

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.

Sponsor: Beijing Anzhen Hospital

View on ClinicalTrials.gov

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.

Official title: A Prospective, Longitudinal, Multi-modal Study Evaluating the Utility of Acute Phase UFR (IVUS-FFR) to Predict Functional Significance in the Stable Phase for Patients With Acute Coronary Syndrome (ACS)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

200

Start Date

2025-12-02

Completion Date

2028-06-22

Last Updated

2025-12-04

Healthy Volunteers

No

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.

Locations (1)

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, China