Safety and Feasibility of Transcatheter Injectable Hydrogel in Acute STEMI Reperfusion Injury (REFINE Study)

Clinical Application Study on the Safety and Feasibility of Transcatheter Injectable Protein Alginate-based Hydrogel for Alleviating Reperfusion Injury in Acute STEMI

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 Overview

• Status: Not yet recruiting
• Conditions: STEMI - ST Elevation Myocardial Infarction
• Intervention / Treatment: Device: Injectable protein alginate-based hydrogel; Other: No additional intervention

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clinical Medical Director; Phone Number: 86-17621666472; Email: contact@myomedtech.com

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China
      • First Affiliated Hospital of Air Force Medical University
      • Principal Investigator: Fei Li
      • Contact: Clinical Research Associate; Phone Number: 021-0575-88605679; Email: Welly_wwx@126.com
      • Sub-Investigator: Yali Yang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Aged 18 to 80 years;
2. Diagnosed with first-onset acute anterior wall ST-segment elevation myocardial infarction (STEMI), requiring primary percutaneous coronary intervention (PCI) and stent implantation;
3. 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;
4. The time interval from the onset of ischemic symptoms to the first PCI balloon dilation is ≤12 hours;
5. Admission coronary angiography shows that the left anterior descending artery (LAD) has a TIMI flow grade of 0 (complete occlusion), and the TIMI flow grade reaches 3 after stent implantation;
6. Able to understand the purpose of the trial, voluntarily participate in the study, sign the informed consent form personally or via a legal representative, and be willing to complete the follow-up in accordance with the protocol requirements.

Exclusion Criteria:

1. 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;
2. 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;
3. History of previous myocardial infarction, coronary intervention (PCI), or coronary artery bypass grafting (CABG);
4. Cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 3 months;
5. Heart failure severity at admission reaches Killip classification Grade III or above;
6. Complicated with malignant arrhythmia, complete atrioventricular block, or new-onset complete left bundle branch block (LBBB);
7. Diagnosed or suspected aortic dissection;
8. Diabetes mellitus with severe complications;
9. Complicated with atrial fibrillation and receiving only warfarin treatment, or with a high bleeding risk;
10. Received thrombolytic therapy prior to PCI;
11. Diameter of the infarct-related artery < 2 mm or abundant coronary collateral circulation in the risk area;
12. Coronary angiography indicates diffuse vascular lesions or severe calcification that may affect the absorption of protein alginate-based hydrogel;
13. Severe complications (e.g., coronary artery rupture, perforation, or stent dislodgement) occurring during PCI;
14. Received coronary bioresorbable stent implantation;
15. Complicated with severe acute infection requiring systemic treatment;
16. Currently diagnosed with malignant tumor or receiving malignant tumor treatment;
17. Severe autoimmune disease requiring therapeutic intervention;
18. History of severe anemia (hemoglobin < 60 g/L) or thrombocytopenia (platelet count < 100×10⁹/L);
19. Known renal insufficiency (including estimated creatinine clearance < 30 ml/min/1.73 m², or receiving treatment for severe renal insufficiency);
20. Alanine aminotransferase (ALT) level exceeding 3 times the upper limit of normal, with the investigator judging clinically significant liver dysfunction;
21. Known allergy to the study product or any radiocontrast agent;
22. Contraindications to cardiovascular magnetic resonance (CMR) examination (e.g., implanted cardiac pacemaker, implantable cardioverter-defibrillator, nerve stimulator, cerebral aneurysm clip, cochlear implant, or claustrophobia);
23. Cognitive dysfunction, dementia, or severe mental illness;
24. Currently participating in other clinical trials and have not yet reached the primary endpoint;
25. Expected survival period < 1 year due to comorbidities;
26. Pregnant or lactating women, or fertile subjects who do not take effective medical contraceptive measures during the study period;
27. Other factors that the investigator deems may have a significant impact on result judgment or the safety and efficacy of the subjects.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hydrogel Group	Device: Injectable protein alginate-based hydrogel; Experimental group: PCI combined with the locally injectable inert material
Other: Blank Control Group	Other: No additional intervention; Conventional PCI procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Myomed Technology (Shaoxing) Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): May 30, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: May 9, 2026
• First Submitted That Met QC Criteria: May 15, 2026
• First Posted (Actual): May 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Myocardial Ischemia; Myocardial Infarction; Ischemia; Pathological Conditions, Signs and Symptoms; ST Elevation Myocardial Infarction
• Other Study ID Numbers: MR-002-CARP-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No