Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-01-02 @ 6:50 AM
Study NCT ID:
NCT06491667
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NLR AND CRP Useful as Cost-Effective Preliminary Prognostic Markers in ST-Elevation Myocardial Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-02-07', 'releaseDate': '2025-01-14'}], 'estimatedResultsFirstSubmitDate': '2025-01-14'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072657', 'term': 'ST Elevation Myocardial Infarction'}], 'ancestors': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-08', 'studyFirstSubmitDate': '2024-07-01', 'studyFirstSubmitQcDate': '2024-07-08', 'lastUpdatePostDateStruct': {'date': '2024-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neutrophil-lymphocyte ratio', 'timeFrame': '6 months', 'description': 'Explore the role of Neutrophil-lymphocyte ratio in predicting the imediate and short-term prognosis in ST-segment elevation myocardial infarction'}, {'measure': 'C-reactive protein', 'timeFrame': '6 months', 'description': 'C-reactive protein in predicting the imediate and short-term prognosis in ST-segment elevation myocardial infarction'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['STEMI']}, 'referencesModule': {'references': [{'pmid': '18452792', 'type': 'RESULT', 'citation': 'Gualandro DM, Caramelli B, Yu PC, Marques AC, Calderaro D. Perioperative myocardial infarction has been forgotten. J Am Coll Cardiol. 2008 May 6;51(18):1825-6; author reply 1826. doi: 10.1016/j.jacc.2008.01.035. No abstract available.'}, {'pmid': '24436429', 'type': 'RESULT', 'citation': 'Sahoo S, Losordo DW. Exosomes and cardiac repair after myocardial infarction. Circ Res. 2014 Jan 17;114(2):333-44. doi: 10.1161/CIRCRESAHA.114.300639.'}, {'pmid': '20644187', 'type': 'RESULT', 'citation': 'Kuklina EV, Yoon PW, Keenan NL. Prevalence of coronary heart disease risk factors and screening for high cholesterol levels among young adults, United States, 1999-2006. Ann Fam Med. 2010 Jul-Aug;8(4):327-33. doi: 10.1370/afm.1137.'}, {'pmid': '11877368', 'type': 'RESULT', 'citation': 'Libby P, Ridker PM, Maseri A. Inflammation and atherosclerosis. Circulation. 2002 Mar 5;105(9):1135-43. doi: 10.1161/hc0902.104353.'}]}, 'descriptionModule': {'briefSummary': 'Acute myocardial infarction (AMI) is a serious and fatal cardiovascular emergency and considered the leading cause of mortality worldwide.\n\nAtherosclerosis of coronary arteries which takes decades to manifest clinically, is the primary predisposing pathologic factor responsible for the development of coronary heart disease It has been shown that A complex immune and inflammatory pathophysiological process is thought to be crucial for in the initiation and progression of atherosclerotic plaques.\n\nInflammation is one of the main mechanisms in the pathogenesis of atherosclerosis , Destabilization of chronic artery plaques and development of thrombosis, which are the main mechanisms in the pathophysiology of ST-segment elevation myocardial infarction (STEMI).\n\n, and the interest to the evaluation of inflammatory biomarkers in coronary artery disease (CAD) has been increasing over the last decade .\n\nAlthough numerous inflammatory markers, including troponin T/I, lactate dehydrogenase (LDH), and creatine kinase (CK-MB), are linked to worsened clinical outcomes in both ST elevation and non-ST elevation myocardial infarction (NSTEMI), there is an unmet need for a cost-effective biomarker for impoverished countries of the world .\n\nThe neutrophil-to-lymphocyte ratio (NLR), and C-reactive protein (CRP) ; has emerged as an important inflammatory markers for cardiovascular risk stratification.\n\nAnd are relatively cheap inflammatory markers, can act as a bridge to mitigate the gap in assessing the cardiovascular risk and outcomes', 'detailedDescription': 'Acute myocardial infarction (AMI) is a serious and fatal cardiovascular emergency and considered the leading cause of mortality worldwide.\n\n* Atherosclerosis of coronary arteries which takes decades to manifest clinically, is the primary predisposing pathologic factor responsible for the development of coronary heart disease\n* It has been shown that A complex immune and inflammatory pathophysiological process is thought to be crucial for in the initiation and progression of atherosclerotic plaques\n* Inflammation is one of the main mechanisms in the pathogenesis of atherosclerosis , Destabilization of chronic artery plaques and development of thrombosis, which are the main mechanisms in the pathophysiology of ST-segment elevation myocardial infarction (STEMI) .\n\n , and the interest to the evaluation of inflammatory biomarkers in coronary artery disease (CAD) has been increasing over the last decade .\n* Although numerous inflammatory markers, including troponin T/I, lactate dehydrogenase (LDH), and creatine kinase (CK-MB), are linked to worsened clinical outcomes in both ST elevation and non-ST elevation myocardial infarction (NSTEMI), there is an unmet need for a cost-effective biomarker for impoverished countries of the world\n* The neutrophil-to-lymphocyte ratio (NLR), and C-reactive protein (CRP) ;\n* has emerged as an important inflammatory markers for cardiovascular risk stratification.\n* And are relatively cheap inflammatory markers, can act as a bridge to mitigate the gap in assessing the cardiovascular risk and outcomes In patients with acute myocardial infarction.\n* Recent data indicates a strong independent relationship between increased complications after acute myocardial infarction in patients with a high NLR and high CRP level at admission and the initial post-hospitalization period.\n* Accordingly, we designed this study to assess the predictive value and prognosis of NLR and CRP in ST-elevation myocardial infarction (STEMI).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '\\- Patients with age ≥18 years of either sex, with either increase in serum cardiac biomarkers or ECG are STEMI', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with age ≥18 years of either sex, with either increase in serum cardiac biomarkers or ECG are STEMI.\n\nExclusion Criteria:\n\n* Patients presenting with NSTEMI and unstable angina\n* Patients with any of these associated conditions that can affect NLR or CRP including\n* Inflammatory conditions such as collagen-vascular disorders\n* Acute or chronic infectious diseases.\n* Auto-immune and neoplastic diseases.\n* Chronic hepatic diseases.\n* Renal failure.\n* Thyroid disorders.\n* Previous valvular heart disease.'}, 'identificationModule': {'nctId': 'NCT06491667', 'briefTitle': 'NLR AND CRP Useful as Cost-Effective Preliminary Prognostic Markers in ST-Elevation Myocardial Infarction', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Neutrophil-to-Lymphocyte Ratio AND C-REATIVE PROTEIN Useful as Cost-Effective Preliminary Prognostic Markers in ST-Elevation Myocardial Infarction', 'orgStudyIdInfo': {'id': 'Soh-med-24-0614MS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Elevated NLR and CRP level', 'description': 'Elevated NLR and CRP level', 'interventionNames': ['Diagnostic Test: CBC', 'Diagnostic Test: C-reactive protein']}, {'label': 'Normal NLR and CRP level', 'description': 'Elevated NLR and CRP level', 'interventionNames': ['Diagnostic Test: CBC', 'Diagnostic Test: C-reactive protein']}], 'interventions': [{'name': 'CBC', 'type': 'DIAGNOSTIC_TEST', 'description': 'Explore the role of Neutrophil-lymphocyte ratio C-reactive protein in predicting the imediate and short-term prognosis in ST-segment elevation myocardial infarction', 'armGroupLabels': ['Elevated NLR and CRP level', 'Normal NLR and CRP level']}, {'name': 'C-reactive protein', 'type': 'DIAGNOSTIC_TEST', 'description': 'Explore the role of Neutrophil-lymphocyte ratio C-reactive protein in predicting the imediate and short-term prognosis in ST-segment elevation myocardial infarction', 'armGroupLabels': ['Elevated NLR and CRP level', 'Normal NLR and CRP level']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Magdy M Amin, Professor', 'role': 'CONTACT'}], 'facility': 'Sohag university hospital', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'Albair Y Kaiser, Resident', 'role': 'CONTACT', 'email': 'Alberyouseef@med.edu.eg', 'phone': '01010095136'}, {'name': 'Sharaf El-DEEN Sh Abd-Allah, Professor', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Magdy M Amin, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sohag University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident at Internal Medicine Department Sohag University hospital', 'investigatorFullName': 'Albier Youssef Kaiser', 'investigatorAffiliation': 'Sohag University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-01-14', 'type': 'RELEASE'}, {'date': '2025-02-07', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Albier Youssef Kaiser, Resident at Internal Medicine Department Sohag University hospital, Sohag University'}}}}