[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Myomed Technology (Shaoxing) Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":40},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":5},"100640995","safety-and-feasibility-of-transcatheter-injectable-hydrogel-in-acute-stemi-reperfusion-injury-refine-study-100640995",false,"NCT07601997","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","Inclusion Criteria:\n\n1. Aged 18 to 80 years;\n2. Diagnosed with first-onset acute anterior wall ST-segment elevation myocardial infarction (STEMI), requiring primary percutaneous coronary intervention (PCI) and stent implantation;\n3. 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 \\\u003C40 years old, ≥2.0 mm in males ≥40 years old, and ≥1.5 mm in females of all ages;\n4. The time interval from the onset of ischemic symptoms to the first PCI balloon dilation is ≤12 hours;\n5. 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;\n6. 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.\n\nExclusion Criteria:\n\n1. 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;\n2. 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;\n3. History of previous myocardial infarction, coronary intervention (PCI), or coronary artery bypass grafting (CABG);\n4. Cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 3 months;\n5. Heart failure severity at admission reaches Killip classification Grade III or above;\n6. Complicated with malignant arrhythmia, complete atrioventricular block, or new-onset complete left bundle branch block (LBBB);\n7. Diagnosed or suspected aortic dissection;\n8. Diabetes mellitus with severe complications;\n9. Complicated with atrial fibrillation and receiving only warfarin treatment, or with a high bleeding risk;\n10. Received thrombolytic therapy prior to PCI;\n11. Diameter of the infarct-related artery \\\u003C 2 mm or abundant coronary collateral circulation in the risk area;\n12. Coronary angiography indicates diffuse vascular lesions or severe calcification that may affect the absorption of protein alginate-based hydrogel;\n13. Severe complications (e.g., coronary artery rupture, perforation, or stent dislodgement) occurring during PCI;\n14. Received coronary bioresorbable stent implantation;\n15. Complicated with severe acute infection requiring systemic treatment;\n16. Currently diagnosed with malignant tumor or receiving malignant tumor treatment;\n17. Severe autoimmune disease requiring therapeutic intervention;\n18. History of severe anemia (hemoglobin \\\u003C 60 g\u002FL) or thrombocytopenia (platelet count \\\u003C 100×10⁹\u002FL);\n19. Known renal insufficiency (including estimated creatinine clearance \\\u003C 30 ml\u002Fmin\u002F1.73 m², or receiving treatment for severe renal insufficiency);\n20. Alanine aminotransferase (ALT) level exceeding 3 times the upper limit of normal, with the investigator judging clinically significant liver dysfunction;\n21. Known allergy to the study product or any radiocontrast agent;\n22. Contraindications to cardiovascular magnetic resonance (CMR) examination (e.g., implanted cardiac pacemaker, implantable cardioverter-defibrillator, nerve stimulator, cerebral aneurysm clip, cochlear implant, or claustrophobia);\n23. Cognitive dysfunction, dementia, or severe mental illness;\n24. Currently participating in other clinical trials and have not yet reached the primary endpoint;\n25. Expected survival period \\\u003C 1 year due to comorbidities;\n26. Pregnant or lactating women, or fertile subjects who do not take effective medical contraceptive measures during the study period;\n27. Other factors that the investigator deems may have a significant impact on result judgment or the safety and efficacy of the subjects.","ALL","18 Years","80 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"NA","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.",[27],"STEMI - ST Elevation Myocardial Infarction","NOT_YET_RECRUITING","2026-05-15",{"date":31,"type":32},"2026-05-22","ACTUAL",{"date":34,"type":21},"2026-05-30",{"date":36,"type":21},"2027-04-30",{"name":38,"class":39},"Myomed Technology (Shaoxing) Co., Ltd.","INDUSTRY",""]