Intravascular Ultrasound guidaNce versuS angIoGrapHy Guidance in Patients With ST-segment Elevation Myocardial Infarction

Official title

Intravascular Ultrasound guidaNce versuS angIoGrapHy Guidance in Primary percuTaneous Coronary Intervention for Patients With ST-segment Elevation Myocardial Infarction

Overview

STEMI represents the subtype of ACS with the worst prognosis, associated with high mortality and an elevated risk of complications. The use of IVI guidance holds the potential to reduce the incidence of MACE. In previous studies, there has been limited research on intravascular imaging in the context of primary revascularization procedures for STEMI, and no large-scale cohort study has compared the differences in clinical outcomes between IVI-guided and angiography-guided primary revascularization. Therefore, we conducted this large-scale randomized controlled trial to compare IVI-guided primary PCI versus coronary angiography-guided primary PCI in patients with STEMI.

Detailed description

This study is a prospective, multicenter, randomized controlled, superiority clinical trial. Eligible subjects who meet the inclusion/exclusion criteria will be randomly assigned in a 1:1 ratio to either the IVUS-guided strategy (experimental group) or the conventional coronary angiography-guided strategy (control group). The study plans to enroll at least 2488 subjects, with 1244 subjects in each of the experimental and control groups. Zhongshan Hospital, Fudan University serves as the lead center. A competitive enrollment approach will be adopted, with the number of cases enrolled by the lead center not exceeding 50% of the total sample size.

In the IVUS group, intravascular ultrasound (IVUS) will be used for guidance; the use of high-frequency intravascular ultrasound (resolution ≥ 50 MHz) is encouraged, though not mandatory.

Interventions

• Procedure Intravascular Ultrasound
  a catheter equipped with an ultrasound transducer is advanced over a guidewire into the vessel lumen distal to the target coronary lesion. Then, while slowly withdrawing the catheter, 360-degree cross-sectional images of the vessel are acquired to accurately measure lumen dimensions, assess plaque characteristics, select an appropriately sized stent, and confirm that after stent implantation the stent is fully apposed, well expanded, and free of vascular complications.
• Procedure Coronary angiography guidance
  A catheter is inserted through a peripheral artery (e.g., femoral or radial artery) and advanced to the ostium of the coronary arteries under fluoroscopic guidance. Once positioned, contrast medium is injected while X-ray images are acquired to visualize the coronary artery lumen and detect any stenoses or occlusions.

Primary outcome measures

• Primary target vessel failure (TVF) rate [Time frame: 1 year]

Secondary outcome measures (6)

• Lesion success rate [Time frame: Perioperative]
• Clinical success rate [Time frame: Pre-discharge]
• Mortality rate [Time frame: 1 Year]
• Incidence of myocardial infarction [Time frame: 1 year]
• Revascularization [Time frame: 1 year]
• Stent thrombosis [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

• Patients diagnosed with acute ST-segment elevation myocardial infarction (STEMI) who have an indication for emergency interventional therapy;
• Subjects who are eligible to undergo primary percutaneous coronary intervention (PCI);
• Subjects or their authorized family members voluntarily agree to participate in the clinical trial and sign the written informed consent form;
• The IVUS catheter is expected to pass through the target lesion to complete the examination.

Exclusion criteria

• Patients with cardiogenic shock or severe heart failure (Killip class IV);
• Patients who have previously undergone coronary artery bypass grafting (CABG);
• Patients with coma or disturbance of consciousness;
• Patients who are expected to be intolerant to long-term antiplatelet therapy;
• Pregnant women;
• Life expectancy < 1 year;
• Currently participating in another drug/device clinical trial and not having reached the primary endpoint;
• Poor compliance, expected to be unable to complete follow-up.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Diagnostic

Study locations

China · 1 center

• Zhongshan Hospital — Shanghai

Identifiers

NCT: NCT07616024 · B2025-555 · ChiCTR2600124260

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)
• ChiCTR ChiCTR2600124260 (Chinese Clinical Trial Registry)

View this study on ClinicalTrials.gov ↗