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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydrogel Group | Experimental |
| |
| Blank Control Group | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Injectable protein alginate-based hydrogel | Device | Experimental group: PCI combined with the locally injectable inert material |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 7 days, 3 months and 6 months post-procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of serious adverse events and device-related adverse events | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Medical Director | Contact | 86-17621666472 | contact@myomedtech.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Air Force Medical University | Xi'an | Shaanxi | China |
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| No additional intervention | Other | Conventional PCI procedure |
|
| Immediately after the procedure |
| AUC of CK-MB and hs-cTnI | baseline, 1 day, 3 days and 7 days post-procedure |
| Changes in interleukin-6 (IL-6) and tumor necrosis factor-α (TNF-α) levels | 1 day, 3 days and 7days post-procedure |
| Concentrations of BNP/NT-proBNP and hsCRP | 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. | CMR and TTE | 7 days, 3 months and 6 months post-procedure |
| To evaluate changes in mean Segmental Wall Thickening Rate (SWTR) of target segments. | CMR | 7 days, 3 months and 6 months post-procedure |
| To evaluate changes in left ventricular global longitudinal strain (LVGLS). | CMR and TTE | 7 days, 3 months and 6 months post-procedure |
| To evaluate changes in myocardial perfusion status | CMR first pass perfusion imaging (PFI) | 7 days, 3 months and 6 months post-procedure |
| To evaluate changes in myocardial extracellular volume (ECV). | CMR | 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) | 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) | 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) | 7 days, 3 months and 6 months post-procedure |
| To evaluate changes in Transmural Myocardial Infarction (TMI) grade | CMR | 7 days, 3 months and 6 months post-procedure |
| To evaluate changes in intramyocardial hemorrhage (IMH) area. | CMR | 7 days, 3 months and 6 months post-procedure |
| To evaluate changes in myocardial infarct size | CMR | 7 days, 3 months and 6 months post-procedure |
| Changes in NYHA classification | 7 days, 30 days, 3 months and 6 months post-procedure |
| Cardiovascular mortality | 6 months post-procedure |
| Incidence of recurrent myocardial infarction | 6 months post-procedure |
| Heart failure readmission rate | 6 months post-procedure |
| All-cause mortality | 6 months post-procedure |
| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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