The purpose of this clinical trial is to preliminarily evaluate the safety and feasibility of the transcatheter injectable protein alginate-based hydrogel developed and manufactured by Myomed Technology (Shaoxing) Co., Ltd. in alleviating reperfusion injury in acute STEMI. This is a randomized controlled trial with a blank control group (conventional PCI treatment). A total of 20 patients will be enrolled in a 1:1 ratio into the test group and the control group.
Aged 18 to 80 years;
Diagnosed with first-onset acute anterior wall ST-segment elevation myocardial infarction (STEMI), requiring primary percutaneous coronary intervention (PCI) and stent implantation;
Ischemic symptoms (e.g., chest pain, precordial discomfort) persist for >30 minutes, and electrocardiographic findings meet the following criteria: ST-segment (J-point) elevation ≥1.0 mm (i.e., amplitude 0.1 mV) in all conventional leads except leads V2 and V3. For leads V2 and V3, the ST-segment elevation criteria are: ≥2.5 mm in males <40 years old, ≥2.0 mm in males ≥40 years old, and ≥1.5 mm in females of all ages;
The time interval from the onset of ischemic symptoms to the first PCI balloon dilation is ≤12 hours;
Complicated with cardiogenic shock or cardiac arrest; or complicated with acute myocardial infarction mechanical complications requiring surgical or interventional intervention (e.g., ventricular septal perforation, papillary muscle rupture, free wall rupture), or complicated with giant left ventricular aneurysm;
Previously diagnosed with hypertrophic cardiomyopathy, hemodynamically significant congenital heart disease, severe valvular heart disease, chronic cor pulmonale, chronic heart failure, or with a history of cardiac tamponade, pericarditis, or myocarditis;
History of previous myocardial infarction, coronary intervention (PCI), or coronary artery bypass grafting (CABG);
Cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 3 months;
Parallel
Injectable protein alginate-based hydrogel
DeviceExperimental group: PCI combined with the locally injectable inert material
No additional intervention
Other interventionConventional PCI procedure
Incidence of Major Adverse Events (MAEs) within 30 days after surgery
Defined as all-cause death, stroke, target vessel myocardial infarction, new-onset severe heart failure, cardiac arrest, cardiogenic shock, sustained ventricular arrhythmia, target vessel revascularization, and any device-related complications.
Myocardial Salvage Index (MSI)
Score range: 0 to 1.0. Higher MSI values indicate better myocardial salvage and superior clinical outcome; lower values indicate smaller salvaged myocardial area and worse outcome.
Incidence of serious adverse events and device-related adverse events
Immediate surgical success
Defined as successful delivery of the investigational product to the predefined target site via catheter, satisfactory immediate angiographic results, uneventful catheter withdrawal, and absence of serious adverse events throughout the procedure.
AUC of CK-MB and hs-cTnI
Changes in interleukin-6 (IL-6) and tumor necrosis factor-α (TNF-α) levels
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