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NCT07264881Not yet recruiting

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.

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)

Source: ClinicalTrials.gov · Last updated 4 Dec 2025

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
200 (estimated)
First submitted
24 Nov 2025
Start date
2 Dec 2025
Primary completion date
22 Jun 2027
Lead sponsor
Beijing Anzhen Hospital
NCT number
NCT07264881

What you commit to

  • Study type: Observational
  • Planned participants: 200
  • From 2 Dec 2025 to the primary completion date, 22 Jun 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior history of Coronary Artery Bypass Grafting (CABG) surgery.The target NCV has received prior PCI (e.g., existing stent) or surgical revascularization.
  • Standard contraindications to CMR examination (e.g., claustrophobia, non-MRI-compatible metallic implants/pacemakers).
  • Currently participating in another interventional (drug or device) clinical study.

Other illness

  • 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.
  • 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.
  • Any other condition which, in the investigator's opinion, makes the participant unsuitable for enrollment (e.g., severe valvular heart disease, cardiomyopathy).

Lab values

  • Severe renal insufficiency (eGFR \< 30 ml/min/1.73m²) or currently undergoing chronic dialysis.

Other

  • Presence of cardiogenic shock on presentation, or persistent hemodynamic instability despite successful PCI of the culprit vessel.
  • The target NCV is a Chronic Total Occlusion (CTO).

Who the study is looking for

  • 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).

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Beijing Anzhen Hospital, Capital Medical University
Coordinator of this site? Confirm its status
BeijingChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.