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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

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

Вторичные конечные точки (12)

• Incidence of serious adverse events and device-related adverse events [Срок оценки: 7 days, 30 days, 3 months, and 6 months post-procedure]
• Immediate surgical success [Срок оценки: Immediately after the procedure]
• AUC of CK-MB and hs-cTnI [Срок оценки: baseline, 1 day, 3 days and 7 days post-procedure]
• Changes in interleukin-6 (IL-6) and tumor necrosis factor-α (TNF-α) levels [Срок оценки: 1 day, 3 days and 7days post-procedure]
• Concentrations of BNP/NT-proBNP and hsCRP [Срок оценки: 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. [Срок оценки: 7 days, 3 months and 6 months post-procedure]
• To evaluate changes in mean Segmental Wall Thickening Rate (SWTR) of target segments. [Срок оценки: 7 days, 3 months and 6 months post-procedure]
• To evaluate changes in left ventricular global longitudinal strain (LVGLS). [Срок оценки: 7 days, 3 months and 6 months post-procedure]
• To evaluate changes in myocardial perfusion status [Срок оценки: 7 days, 3 months and 6 months post-procedure]
• To evaluate changes in myocardial extracellular volume (ECV). [Срок оценки: 7 days, 3 months and 6 months post-procedure]
• To evaluate change in left ventricular end-diastolic volume (LVEDV) [Срок оценки: 7 days, 3 months and 6 months post-procedure]
• To evaluate change in left ventricular end-systolic volume (LVESV) [Срок оценки: 7 days, 3 months and 6 months post-procedure]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• First Affiliated Hospital of Air Force Medical University — Сиань

Идентификаторы

NCT: NCT07601997 · MR-002-CARP-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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