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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
20
Experimental group: PCI combined with the locally injectable inert material
Conventional PCI procedure
First Affiliated Hospital of Air Force Medical University
Xi'an, Shaanxi, China
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.
Time frame: within 30 days
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.
Time frame: 7 days, 3 months and 6 months post-procedure.
Incidence of serious adverse events and device-related adverse events
Time frame: 7 days, 30 days, 3 months, and 6 months post-procedure
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.
Time frame: Immediately after the procedure
AUC of CK-MB and hs-cTnI
Time frame: baseline, 1 day, 3 days and 7 days post-procedure
Changes in interleukin-6 (IL-6) and tumor necrosis factor-α (TNF-α) levels
Time frame: 1 day, 3 days and 7days post-procedure
Concentrations of BNP/NT-proBNP and hsCRP
Time frame: baseline, 1 day, 3 days, 7days and 6 months post-procedure
To assess changes in the grade of Segmental Wall Motion Abnormality (SWMA) in target segments based on the ASE 17-segment model, as well as the reduction rate of segments with wall motion abnormalities.
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CMR and TTE
Time frame: 7 days, 3 months and 6 months post-procedure
To evaluate changes in mean Segmental Wall Thickening Rate (SWTR) of target segments.
CMR
Time frame: 7 days, 3 months and 6 months post-procedure
To evaluate changes in left ventricular global longitudinal strain (LVGLS).
CMR and TTE
Time frame: 7 days, 3 months and 6 months post-procedure
To evaluate changes in myocardial perfusion status
CMR first pass perfusion imaging (PFI)
Time frame: 7 days, 3 months and 6 months post-procedure
To evaluate changes in myocardial extracellular volume (ECV).
CMR
Time frame: 7 days, 3 months and 6 months post-procedure
To evaluate change in left ventricular end-diastolic volume (LVEDV)
Detection method: cardiac magnetic resonance (CMR) and transthoracic echocardiography (TTE)
Time frame: 7 days, 3 months and 6 months post-procedure
To evaluate change in left ventricular end-systolic volume (LVESV)
Detection method: cardiac magnetic resonance (CMR) and transthoracic echocardiography (TTE)
Time frame: 7 days, 3 months and 6 months post-procedure
To evaluate change in left ventricular ejection fraction (LVEF)
Detection method: cardiac magnetic resonance (CMR) and transthoracic echocardiography (TTE)
Time frame: 7 days, 3 months and 6 months post-procedure
To evaluate changes in Transmural Myocardial Infarction (TMI) grade
CMR
Time frame: 7 days, 3 months and 6 months post-procedure
To evaluate changes in intramyocardial hemorrhage (IMH) area.
CMR
Time frame: 7 days, 3 months and 6 months post-procedure
To evaluate changes in myocardial infarct size
CMR
Time frame: 7 days, 3 months and 6 months post-procedure
Changes in NYHA classification
Time frame: 7 days, 30 days, 3 months and 6 months post-procedure
Cardiovascular mortality
Time frame: 6 months post-procedure
Incidence of recurrent myocardial infarction
Time frame: 6 months post-procedure
Heart failure readmission rate
Time frame: 6 months post-procedure
All-cause mortality
Time frame: 6 months post-procedure