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 | Not Yet Recruiting FDA Device

• 1 other identifier: KS2025241
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Acute Coronary Syndrome; Fractional Flow Reserve,; Intravascular Ultrasound; Virtual Fractional Flow Reserve; Functional Drift; Coronary Microvascular Dysfunction; Index of Microcirculatory Resistance; Non-Culprit Vessel; ST Elevation Myocardial Infarction; Non-ST Elevation Myocardial Infarction; Cardiac Magnetic Resonance; Microvascular Obstruction; Staged Revascularization; Computational Fluid Dynamics

Outcome Measures

Primary Outcomes (1)

• Diagnostic Performance of Acute UFR (T0) Compared to Staged pFFR (T1) in Non-Culprit Vessels

  To assess the diagnostic performance of UFR measured at T0 (Acute) against the gold-standard pFFR (threshold ≤ 0.80) measured at T1 (30 Days). Performance will be assessed by 1) Diagnostic accuracy (Sensitivity, Specificity, PPV, NPV), 2) Correlation (Pearson coefficient and Bland-Altman analysis), and 3) Comparison of Area Under the Curve (AUC).

  Baseline (T0) and 30 Days (T1)

Secondary Outcomes (4)

• Functional Re-classification Rate ("Functional Drift") from T0 to T1 (STEMI vs. NSTEMI)

  Baseline (T0) and 30 Days (T1)

• Correlation between Acute Culprit Vessel IMR and Sub-Acute MVO (Coupling 1)

  Baseline (T0) and 3-5 Days (T-CMR)

• Longitudinal Stability of In-Stent pFFR and UFR (Culprit Vessel Evolution)

  Baseline (T0) and 1 Year (T2)

• Prognostic Value of T1 NCV Functional Status on 1-Year MACE

  From 30 Days (T1) up to 1 Year (T2)

Study Arms (1)

ACS with MVD Cohort

A single prospective, observational cohort of 200 patients presenting with Acute Coronary Syndrome (ACS) and multi-vessel disease (MVD). This single cohort will be pre-stratified at enrollment into two groups for comparative analysis: 1) STEMI (N≈100) and 2) High-Risk NSTEMI (N≈100). All participants undergo the identical longitudinal assessment.

Diagnostic Test: IVUS-based Fractional Flow Reserve (UFR); Diagnostic Test: Invasive Coronary Physiology Measurement (FFR/RFR/IMR); Diagnostic Test: Cardiac Magnetic Resonance (CMR)

Interventions

IVUS-based Fractional Flow Reserve (UFR) DIAGNOSTIC_TEST

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.

ACS with MVD Cohort

Invasive Coronary Physiology Measurement (FFR/RFR/IMR) DIAGNOSTIC_TEST

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.

ACS with MVD Cohort

Cardiac Magnetic Resonance (CMR) DIAGNOSTIC_TEST

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.

ACS with MVD Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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).

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Sites (1)

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, 100029, China

Location

Related Publications (5)

• Yu W, Tanigaki T, Ding D, Wu P, Du H, Ling L, Huang B, Li G, Yang W, Zhang S, Yan F, Okubo M, Xu B, Matsuo H, Wijns W, Tu S. Accuracy of Intravascular Ultrasound-Based Fractional Flow Reserve in Identifying Hemodynamic Significance of Coronary Stenosis. Circ Cardiovasc Interv. 2021 Feb;14(2):e009840. doi: 10.1161/CIRCINTERVENTIONS.120.009840. Epub 2021 Feb 5.

  PMID: 33541105 RESULT

• Nijveldt R, Maeng M, Beijnink CWH, Piek JJ, Al-Lamee RK, Raposo L, Baptista SB, Escaned J, Davies J, Klem I, Yosofi B, van Geuns RM, Frederiksen CA, Jakobsen L, El Barzouhi A, van der Heijden DJ, Ilhan M, Rasoul S, Brinckman S, Saraber C, Jones DA, Petersen SE, Podlesnikar T, Bunc M, Beijk MAM, Piers LH, van Rees JB, Seligman H, Cole G, Iglesias JF, Degrauwe S, van 't Hof AWJ, Lipsic E, Pundziute-do Prado G, Chattranukulchai P, Rodriguez-Palomares JF, Rigger J, Meuwissen M, Kleijn L, Pereira B, Monti L, van der Schaaf RJ, Sanchis J, Belli G, Tijssen JGP, Thim T, van Royen N; iMODERN Investigators. Immediate or Deferred Nonculprit-Lesion PCI in Myocardial Infarction. N Engl J Med. 2026 Mar 5;394(10):958-968. doi: 10.1056/NEJMoa2512918. Epub 2025 Oct 28.

  PMID: 41159879 RESULT

• Mehta SR, Wood DA, Storey RF, Mehran R, Bainey KR, Nguyen H, Meeks B, Di Pasquale G, Lopez-Sendon J, Faxon DP, Mauri L, Rao SV, Feldman L, Steg PG, Avezum A, Sheth T, Pinilla-Echeverri N, Moreno R, Campo G, Wrigley B, Kedev S, Sutton A, Oliver R, Rodes-Cabau J, Stankovic G, Welsh R, Lavi S, Cantor WJ, Wang J, Nakamya J, Bangdiwala SI, Cairns JA; COMPLETE Trial Steering Committee and Investigators. Complete Revascularization with Multivessel PCI for Myocardial Infarction. N Engl J Med. 2019 Oct 10;381(15):1411-1421. doi: 10.1056/NEJMoa1907775. Epub 2019 Sep 1.

  PMID: 31475795 RESULT

• van der Hoeven NW, Janssens GN, de Waard GA, Everaars H, Broyd CJ, Beijnink CWH, van de Ven PM, Nijveldt R, Cook CM, Petraco R, Ten Cate T, von Birgelen C, Escaned J, Davies JE, van Leeuwen MAH, van Royen N. Temporal Changes in Coronary Hyperemic and Resting Hemodynamic Indices in Nonculprit Vessels of Patients With ST-Segment Elevation Myocardial Infarction. JAMA Cardiol. 2019 Aug 1;4(8):736-744. doi: 10.1001/jamacardio.2019.2138.

  PMID: 31268466 RESULT

• Puymirat E, Cayla G, Simon T, Steg PG, Montalescot G, Durand-Zaleski I, le Bras A, Gallet R, Khalife K, Morelle JF, Motreff P, Lemesle G, Dillinger JG, Lhermusier T, Silvain J, Roule V, Labeque JN, Range G, Ducrocq G, Cottin Y, Blanchard D, Charles Nelson A, De Bruyne B, Chatellier G, Danchin N; FLOWER-MI Study Investigators. Multivessel PCI Guided by FFR or Angiography for Myocardial Infarction. N Engl J Med. 2021 Jul 22;385(4):297-308. doi: 10.1056/NEJMoa2104650. Epub 2021 May 16.

  PMID: 33999545 RESULT

MeSH Terms

Conditions

Acute Coronary Syndrome; ST Elevation Myocardial Infarction; Non-ST Elevated Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Hai Gao, MD, PHD

  Beijing Anzhen Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lin Wang, MD PHD

CONTACT

008613552122249; linwang5215@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 4, 2025
• Study Start: December 2, 2025
• Primary Completion (Estimated): June 22, 2027
• Study Completion (Estimated): June 22, 2028
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 6 months after the date of the primary manuscript publication, and remaining available for 5 years after the final publication of the main study results.
• Access Criteria: Access will be granted to qualified, non-commercial scientific researchers from accredited institutions. Requests must be submitted as a detailed research proposal to the Principal Investigator (PI) and will be reviewed by the Study Steering Committee based on scientific merit and alignment with ethical standards. Approved researchers must sign a formal Data Access Agreement that prohibits attempts at re-identification. Data will be provided via a secure, encrypted platform

Locations

CN (1)