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

Official title

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

Overview

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.

Interventions

• Device Injectable protein alginate-based hydrogel
  Experimental group: PCI combined with the locally injectable inert material
• Other No additional intervention
  Conventional PCI procedure

Primary outcome measures

• Incidence of Major Adverse Events (MAEs) within 30 days after surgery [Time frame: within 30 days]
• Myocardial Salvage Index (MSI) [Time frame: 7 days, 3 months and 6 months post-procedure.]

Secondary outcome measures (12)

• 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 [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. [Time frame: 7 days, 3 months and 6 months post-procedure]
• To evaluate changes in mean Segmental Wall Thickening Rate (SWTR) of target segments. [Time frame: 7 days, 3 months and 6 months post-procedure]
• To evaluate changes in left ventricular global longitudinal strain (LVGLS). [Time frame: 7 days, 3 months and 6 months post-procedure]
• To evaluate changes in myocardial perfusion status [Time frame: 7 days, 3 months and 6 months post-procedure]
• To evaluate changes in myocardial extracellular volume (ECV). [Time frame: 7 days, 3 months and 6 months post-procedure]
• To evaluate change in left ventricular end-diastolic volume (LVEDV) [Time frame: 7 days, 3 months and 6 months post-procedure]
• To evaluate change in left ventricular end-systolic volume (LVESV) [Time frame: 7 days, 3 months and 6 months post-procedure]

Eligibility criteria

Inclusion criteria

• 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;
• 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;
• 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

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

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

Single blind

Primary purpose

Treatment

Study locations

China · 1 center

• First Affiliated Hospital of Air Force Medical University — Xi'an

Identifiers

NCT: NCT07601997 · MR-002-CARP-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗