[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640995":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":29,"locations":35,"responsibleParty":59,"collaborators":11,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":11,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":11,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":11,"overallStatus":80,"whyStopped":11,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Myomed Technology (Shaoxing) Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Hydrogel Group","EXPERIMENTAL",null,[13],"Device: Injectable protein alginate-based hydrogel",{"label":15,"type":16,"description":11,"interventionNames":17},"Blank Control Group","OTHER",[18],"Other: No additional intervention",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DEVICE","Injectable protein alginate-based hydrogel","Experimental group: PCI combined with the locally injectable inert material",[9],{"type":16,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"No additional intervention","Conventional PCI procedure",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},"Clinical Medical Director","CONTACT","86-17621666472","contact@myomedtech.com",[36],{"facility":37,"status":11,"city":38,"state":39,"zip":11,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"First Affiliated Hospital of Air Force Medical University","Xi'an","Shaanxi","China","CN",{"type":43,"coordinates":44},"Point",[45,46],108.92861,34.25833,{"lat":46,"lon":45},[49,53,56],{"name":50,"role":32,"phone":51,"phoneExt":11,"email":52},"Clinical Research Associate","021-0575-88605679","Welly_wwx@126.com",{"name":54,"role":55,"phone":11,"phoneExt":11,"email":11},"Fei Li","PRINCIPAL_INVESTIGATOR",{"name":57,"role":58,"phone":11,"phoneExt":11,"email":11},"Yali Yang","SUB_INVESTIGATOR",{"type":60,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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":72,"type":73},20,"ESTIMATED","INTERVENTIONAL",[76],"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.",[79],"STEMI - ST Elevation Myocardial Infarction","NOT_YET_RECRUITING","2026-05-15",{"date":83,"type":84},"2026-05-22","ACTUAL",{"date":86,"type":73},"2026-05-30",{"date":88,"type":73},"2027-04-30",{"name":5,"class":6},1]