Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2025-12-25 @ 5:22 PM
Study NCT ID:
NCT05677503
Status:
UNKNOWN
Last Update Posted:
2023-01-12
First Post:
2022-12-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Determination of the Red Cell Distribution Width, NT-proBNP and cTnT in Acute Myocardial Infarction Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-07-26', 'releaseDate': '2024-02-18'}], 'estimatedResultsFirstSubmitDate': '2024-02-18'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'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': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-01-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-11', 'studyFirstSubmitDate': '2022-12-23', 'studyFirstSubmitQcDate': '2023-01-09', 'lastUpdatePostDateStruct': {'date': '2023-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'complete blood count (CBC)', 'timeFrame': '7 months', 'description': 'measurement of CBC levels will be performed'}, {'measure': 'Level of (NT-proBNP)', 'timeFrame': '7 months', 'description': 'measurement of serum NT-proBNP level will be performed'}, {'measure': 'Level of (cTnT)', 'timeFrame': '7 months', 'description': 'measurement of cTnT level will be performed'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'the study is to investigate the relationship of several parameters of complete blood count (CBC) including RDW with N-terminal pro-B-type natriuretic peptide (NT-proBNP) and cardiac troponin T (cTnT) in a cohort of acute myocardial infarction (AMI) patients.', 'detailedDescription': 'Patients and methods:\n\n* Type of study: Observational prospective study\n* Place of study: Sohag cardiology and gastroenterology center, department of cardiology and cardiac care unit.\n* Ethical considerations: This research will be revised by the Scientific Ethical Committee of Sohag University Hospital. Consents will be taken from all patients.\n* Study Methods:\n\n * A prospective study on 30 patients diagnosed as acute myocardial infarction on which measurement of CBC, serum NT-proBNP, and cTnT levels will be performed at the time of admission and by the time of discharge.\n\n 1. Full history:\n\n 1. Personal history: e.g. age, sex and smoking.\n 2. Family history of cardiac diseases\n 3. Medical history of: Hypertension, Ischemic heart disease, prior coronary artery bypass grafting, Prior Percutaneous coronary intervention, Prior Stroke, Prior Atrial fibrillation, therapeutic history\n 2. Detailed clinical examination\n 3. Electrocardiogram\n 4. Laboratory investigation:\n\n 1. Routine investigation in the form of CBC including RDW\n 2. Specific investigation which include NT-proBNP and cTnT'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '\\_All patients included in the study will be subjected to:\n\n1. Full history:\n\n 1. Personal history: e.g. age, sex and smoking.\n 2. Family history of cardiac diseases\n 3. Medical history of: Hypertension, Ischemic heart disease, prior coronary artery bypass grafting, Prior Percutaneous coronary intervention, Prior Stroke, Prior Atrial fibrillation, therapeutic history\n2. Detailed clinical examination\n3. Electrocardiogram\n4. Laboratory investigation:\n\n 1. Routine investigation in the form of CBC including RDW\n 2. Specific investigation which include NT-proBNP and cTnT', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients diagnosed as acute myocardial infarction\n\nExclusion Criteria:\n\nPatient with\n\n* Decompensated heart failure\n* Pulmonary hypertention\n* Acute pulmonary embolism\n* Septic shock'}, 'identificationModule': {'nctId': 'NCT05677503', 'briefTitle': 'Determination of the Red Cell Distribution Width, NT-proBNP and cTnT in Acute Myocardial Infarction Patients', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Determination of the Relationship Between Red Cell Distribution Width, NT-proBNP and cTnT in Acute Myocardial Infarction Patients', 'orgStudyIdInfo': {'id': 'Sohag_Med_22_12_07'}}, 'armsInterventionsModule': {'interventions': [{'name': 'CBC', 'type': 'DIAGNOSTIC_TEST', 'description': 'measurement of CBC will be performed at the time of admission and by the time of discharge'}, {'name': '(NT-proBNP)', 'type': 'DIAGNOSTIC_TEST', 'description': 'measurement of serum NT-proBNP levels will be performed at the time of admission and by the time of discharge'}, {'name': '(cTnT)', 'type': 'DIAGNOSTIC_TEST', 'description': 'measurement of cTnT levels will be performed at the time of admission and by the time of discharge'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident doctor at clinical and chemical pathology department', 'investigatorFullName': 'Hemat Kamel Maarouf', 'investigatorAffiliation': 'Sohag University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-02-18', 'type': 'RELEASE'}, {'date': '2024-07-26', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Hemat Kamel Maarouf, Resident doctor at clinical and chemical pathology department, Sohag University'}}}}