[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559498":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":41,"studyPopulation":26,"armGroups":42,"interventions":54,"overallOfficials":26,"centralContacts":68,"locations":74,"responsibleParty":91,"collaborators":26,"id":95,"slug":26,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":26,"eligibilityCriteria":100,"healthyVolunteers":96,"sex":101,"minAge":102,"maxAge":103,"enrollmentInfo":104,"targetDuration":26,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":26,"overallStatus":77,"whyStopped":26,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Ain Shams University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":26},[9,13],{"measure":10,"description":11,"timeFrame":12},"Evaluation of the marker nitrotyrosine","Measuring serum concentration of nitrotyrosine as an oxidative stress marker","24 hours post PCI",{"measure":14,"description":15,"timeFrame":12},"Evaluation of the marker (MMP-2)","Measuring serum concentration of Matrix metallopeptidase-2 (MMP-2) as a cardiac fibrosis marker.",[17,21,24,28,32],{"measure":18,"description":19,"timeFrame":20},"Assessment of Thrombolysis in Myocardial Infarction (TIMI) flow","Grade 0: No perfusion Grade 1: Penetration without perfusion Grade 2: Partial perfusion Grade 3: Complete perfusion","0-1 hour at the end of PCI",{"measure":22,"description":23,"timeFrame":20},"Assessment of Myocardial Blush Grade","Grade 0: No myocardial blush Grade 1: Minimal myocardial blush Grade 2: Moderate myocardial blush Grade 3: Normal myocardial blush",{"measure":25,"description":26,"timeFrame":27},"Incidence of ST-segment resolution >70 by ECG",null,"60 minutes post PCI",{"measure":29,"description":30,"timeFrame":31},"Echocardiography","Assessment of Left Ventricular Ejection Fraction (LVEF) and left ventricular diastolic and systolic volumes","4 weeks",{"measure":33,"description":34,"timeFrame":31},"Occurrence of Major Adverse Cardiac Events (MACE)","mortality, rehospitalization, reinfarction, arrhythmias, arrest, etc",{"allocation":36,"interventionModel":37,"interventionModelDescription":26,"primaryPurpose":38,"observationalModel":26,"timePerspective":26,"maskingInfo":39},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":40,"maskingDescription":26,"whoMasked":26},"NONE","This study aims to investigate the effects of L-Carnitine on biomarkers of myocardial reperfusion injury in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI by the assessment of the following:\n\n1. Measurement of nitrotyrosine as an oxidative stress marker and Matrix metallopeptidase-2 (MMP-2) as a cardiac fibrosis marker.\n2. Assessment of The TIMI (thrombolysis in myocardial infarction) grade and Myocardial Blush Grade (MBG).\n3. Echocardiography parameters\n\nPatients and Methods:\n\nDesign: Prospective, randomized, open label, controlled clinical trial\n\nPatients: A total of 76 STEMI patients undergoing primary PCI will be enrolled in the study and will be randomly assigned into one of 2 arms:\n\nGroup 1 (Control group) (n=38): STEMI patients undergoing PCI who will receive the standard of care Group 2 (Test group) (n= 38): STEMI patients undergoing PCI who will receive the standard of care in addition to L-Carnitine 5 g intravenous administered as slow Iv push over 2-3 minutes (L-Carnitine 1 gm \u002F 5 mL Injection®, MEPACO, Egypt) prior to PCI and then 2 g orally (Carnitol 500 mg®, Global Napi, Egypt) daily for 4 weeks after PCI",[43,49],{"label":44,"type":45,"description":46,"interventionNames":47},"Control group","EXPERIMENTAL","38 STEMI patients undergoing PCI who will receive the standard of care for 4 weeks and will include the required antiplatelet (Dual Antiplatelet Therapy; DAPT), anticoagulants and anti-ischemic measures (high intensity statin, ACEI or aldosterone) as per latest guidelines recommendations.",[48],"Drug: The standard care for the management of myocardial infarction post PCI",{"label":50,"type":45,"description":51,"interventionNames":52},"Test group","38 STEMI patients undergoing PCI who will receive the standard of care in addition to L-Carnitine 5 g intravenous administered as slow Iv push over 2-3 minutes (L-Carnitine 1 gm \u002F 5 mL Injection®, MEPACO, Egypt) prior to PCI and then 2 g orally (Carnitol 500 mg®, Global Napi, Egypt) daily for 4 weeks after PCI",[53,48],"Drug: L-Carnitine",[55,62],{"type":56,"name":57,"description":58,"armGroupLabels":59,"otherNames":60},"DRUG","L-Carnitine","L-Carnitine 5 g intravenous administered as slow IV push over 2-3 minutes (L-Carnitine 1 gm \u002F 5 mL Injection®, MEPACO, Egypt) and Carnitol 500 mg® Oral, Global Napi, Egypt)",[50],[61],"levocarnitine",{"type":56,"name":63,"description":64,"armGroupLabels":65,"otherNames":66},"The standard care for the management of myocardial infarction post PCI","include the required antiplatelet (Dual Antiplatelet Therapy; DAPT), anticoagulants, and anti-ischemic measures (high-intensity statin, ACEI, or aldosterone) as per latest guidelines recommendations.",[44,50],[67],"Guideline-directed medical therapy for STEMI",[69],{"name":70,"role":71,"phone":72,"phoneExt":26,"email":73},"Mohamed Hamdy Mohamedy","CONTACT","+201151189985","mohamed.hamdy.mh@outlook.com",[75],{"facility":76,"status":77,"city":78,"state":26,"zip":26,"country":79,"countryCode":80,"cosmosGeoPoint":81,"geoPoint":86,"contacts":87},"Ain Shams University Hospitals","RECRUITING","Cairo","Egypt","EG",{"type":82,"coordinates":83},"Point",[84,85],31.24967,30.06263,{"lat":85,"lon":84},[88],{"name":89,"role":71,"phone":26,"phoneExt":26,"email":90},"Ayman Saleh, Professor","maymanmsaleh@yahoo.com",{"type":92,"investigatorFullName":93,"investigatorTitle":94,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Mohamed H. Mohamedy","Teaching assistant at clinical pharmacy department","100559498",false,"NCT06564909","Effect of L-Carnitine on Biomarkers of Myocardial Reperfusion Injury in Patients With STEMI","Effect of L-Carnitine on Biomarkers of Myocardial Reperfusion Injury in Patients With ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention","Inclusion Criteria:\n\n* Female or male aged \\>18 and \\\u003C 75 years.\n* STEMI patients undergoing PCI.\n\nExclusion Criteria:\n\n* Patients with a recent history of myocardial infarction (MI), a previous PCI, a previous coronary artery bypass graft, or any cardiac surgery.\n* A late presentation (\\>12 h), unsuccessful primary PCI (residual stenosis \\>50% in the culprit lesion after procedure),\n* Pretreatment with thrombolytic or glycoprotein IIb\u002FIIIa inhibitor therapy before primary PCI,\n* Concurrent Infectious or active inflammatory disease,\n* Severe liver or renal disease, (aspartate aminotransferase (AST) or alanine transaminase (ALT) \\> 3x ULN or Total bilirubin \\> 3 x ULN), (CrCl \\\u003C 60 ml\u002Fmin (based on the Cockroft-Gault equation)\n* Neoplasm, or hematological disorders\n* Pregnant or breast-feeding patients\n* Active participation in another clinical study\n* Patients taking antioxidant drugs.\n* History of or known allergy or intolerability to the study medications","ALL","18 Years","75 Years",{"count":105,"type":106},76,"ESTIMATED","INTERVENTIONAL",[109],"PHASE2","The study aims is to evaluate the efficacy and tolerability of L-Carnitine on biomarkers of myocardial reperfusion injury in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI by the assessment of nitrotyrosine as an oxidative stress marker and Matrix metallopeptidase-2 (MMP-2) as a cardiac fibrosis marker",[112,113],"Reperfusion Injury, Myocardial","Myocardial Infarction","2025-06-22",{"date":116,"type":117},"2025-06-26","ACTUAL",{"date":119,"type":117},"2025-06-01",{"date":121,"type":106},"2026-03",{"name":5,"class":6},1]