[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604890":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":15,"centralContacts":21,"locations":10,"responsibleParty":27,"collaborators":10,"id":31,"slug":32,"hasResults":33,"nctId":34,"briefTitle":35,"officialTitle":36,"acronym":10,"eligibilityCriteria":37,"healthyVolunteers":33,"sex":38,"minAge":39,"maxAge":10,"enrollmentInfo":40,"targetDuration":43,"studyType":44,"phases":10,"briefSummary":45,"conditions":46,"keywords":49,"overallStatus":60,"whyStopped":10,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":10},{"fullName":5,"class":6},"Assiut University","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Diabetic STEMI Patients",null,"Patients presenting with ST-segment elevation myocardial infarction (STEMI) and a confirmed diagnosis of diabetes mellitus, undergoing primary percutaneous coronary intervention (PCI).",{"label":13,"type":10,"description":14,"interventionNames":10},"Non-Diabetic STEMI Patients","Patients presenting with STEMI and no history or diagnosis of diabetes, undergoing primary PCI.",[16,19],{"name":17,"affiliation":5,"role":18},"Mohamed Abdelghany","STUDY_DIRECTOR",{"name":20,"affiliation":5,"role":18},"Heba Mahmoud Elnaggar",[22],{"name":23,"role":24,"phone":25,"phoneExt":10,"email":26},"David Emil Efraim","CONTACT","+201091620534","David.17289572@med.aun.edu.eg",{"type":28,"investigatorFullName":29,"investigatorTitle":30,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","David Emil Efraim Danial","Resident Cardiologist","100604890","inflammatory-and-hematological-indices-in-diabetic-stemi-patients-undergoing-primary-pci-100604890",false,"NCT07155395","Inflammatory and Hematological Indices in Diabetic STEMI Patients Undergoing Primary PCI","Relationship Between Inflammatory and Hematological Indices and Coronary Artery Disease Severity and Outcome Among Diabetic Patients Undergoing Primary Percutaneous Coronary Intervention","Inclusion Criteria:\n\n* Patients presenting to Assiut University cardiac catheterization laboratory with ST-segment Elevation Myocardial Infarction (STEMI).\n* Managed with primary percutaneous coronary intervention (PPCI).\n\nExclusion Criteria:\n\n* Patients not eligible for PPCI.\n* Patients who underwent thrombolytic therapy or received anti-thrombotics prior to hospital arrival.\n* Prior coronary intervention: history of PCI or CABG.\n* Known hematological disorders:\n\nThalassemia (microcytic anemia, normal iron profile, HbA2 ≥ 3.5% or elevated HbF).\n\nMyelodysplastic syndromes (unexplained cytopenias with ≥10% dysplasia in bone marrow aspirate).\n\nLeukemia (persistent leukocytosis or pancytopenia, blasts ≥20% in peripheral blood).\n\n* Active infection or sepsis at admission (e.g., fever, leukocytosis, elevated CRP \\\u003C100 mg\u002FL without cardiac cause).\n* Known autoimmune or chronic inflammatory diseases (e.g., systemic lupus erythematosus).\n* Known or newly diagnosed malignancy.\n* End-stage renal disease (eGFR \\\u003C30 ml\u002Fmin\u002F1.73 m² or on dialysis).\n* Advanced hepatic impairment (Child-Pugh class C; bilirubin \\>3 mg\u002FdL or ALT\u002FAST \\>3× upper limit of normal).\n* Recent blood transfusion within 3 months.\n* Recent use of steroids, chemotherapy, or immunosuppressive drugs.\n* Mechanical complications or cardiogenic shock prior to or during STEMI presentation (e.g., papillary muscle rupture, ventricular septal defect, need for intra-aortic balloon pump).","ALL","18 Years",{"count":41,"type":42},1000,"ESTIMATED","6 Months","OBSERVATIONAL","ST-segment Elevation Myocardial Infarction (STEMI) remains a major cause of mortality despite the adoption of Primary Percutaneous Coronary Intervention (PPCI) as the standard treatment. However, outcomes still vary significantly among patients, especially between diabetic and non-diabetic cohorts.\n\nThe research question driving this study is: Can hematologic, inflammatory, and thrombotic indices serve as reliable prognostic tools in predicting the no-reflow phenomenon and coronary artery disease (CAD) severity in STEMI patients, particularly among those with diabetes mellitus?\n\nRecent literature identifies inflammation as a key contributor to the pathogenesis and outcomes of Acute Coronary Syndrome (ACS), including the no-reflow phenomenon and Major Adverse Cardiovascular Events (MACE). Markers such as C-reactive protein (CRP), Neutrophil-to-Albumin Ratio (NAR), Red Cell Distribution Width (RDW), Platelet Distribution Width (PDW), Hemoglobin-to-Red Cell Distribution Width ratio (Hb\u002FRDW), and the RDW\u002FPDW ratio have shown individual correlations with poor outcomes. Emerging indices such as the Systemic Immune-Inflammation Index (SII) and the Systemic Inflammatory Response Index (SIRI) further integrate immune and inflammatory components and have shown promise in early risk stratification.\n\nThe current strategy in many cardiac centers relies on angiographic and clinical indicators, which may be insufficient for individualized risk prediction. Hence, incorporating accessible and cost-effective blood-based markers could significantly enhance prognostic accuracy.\n\nThe rationale of this research lies in comparing these indices in diabetic versus non-diabetic STEMI patients, aiming to stratify risk, predict no-reflow, assess coronary artery disease burden using the SYNTAX score, and identify those at risk for early adverse outcomes.",[47,48],"STEMI","Diabete Mellitus",[47,50,51,52,53,54,55,56,57,58,59],"Diabetes","No reflow","SYNTAX","Hb\u002FRDW","RDW\u002FPDW","NAR","SIRI","SII","CRP","PPCI","NOT_YET_RECRUITING","2025-09-01",{"date":63,"type":64},"2025-09-04","ACTUAL",{"date":66,"type":42},"2025-10",{"date":68,"type":42},"2027-04",{"name":5,"class":6}]