Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
Study NCT ID:
NCT05134220
Status:
UNKNOWN
Last Update Posted:
2021-11-24
First Post:
2021-11-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Electrolytes in Chronic Kidney Disease Patients With Acute Coronary Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-02-21', 'releaseDate': '2023-07-05'}], 'estimatedResultsFirstSubmitDate': '2023-07-05'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-11-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2022-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-22', 'studyFirstSubmitDate': '2021-11-06', 'studyFirstSubmitQcDate': '2021-11-22', 'lastUpdatePostDateStruct': {'date': '2021-11-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Chronic kidney disease hospitalization', 'timeFrame': 'from the day of admission to the day of discharge through study completion, an average of 28 weeks, in sohag university hospital', 'description': 'The CKD patient with and without acute coronary syndrome and estimated hazard ratios (HR) by use of multivariable Cox regression models.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Coronary Syndrome']}, 'referencesModule': {'references': [{'pmid': '9531176', 'type': 'BACKGROUND', 'citation': 'Block GA, Hulbert-Shearon TE, Levin NW, Port FK. Association of serum phosphorus and calcium x phosphate product with mortality risk in chronic hemodialysis patients: a national study. Am J Kidney Dis. 1998 Apr;31(4):607-17. doi: 10.1053/ajkd.1998.v31.pm9531176.'}]}, 'descriptionModule': {'briefSummary': 'Study of serum calcium and phosphorus level in chronic kidney disease patients and its relation to occurrence of acute coronary syndrome in them.', 'detailedDescription': 'Prospective study to :\n\n1. find the relation between electrolytes disturbance and renal diseases\n2. the effect of electrolyte abnormalities on atherosclerosis\n3. prevalence of acute coronary syndrome in patients with chronic kidney disease'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'two groups :\n\n1. CKD patients with and without dialysis who admitted to Sohag university hospital with acute coronary syndrome\n2. CKD patients with and without dialysis who admitted to Sohag university hospital with no previous or current history of acute coronary syndrome', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1-The CKD patients with or without dialysis who admitted to coronary care unit with chest pain consistent with ACS with any of following features :\n\n a- Electrocardiogram (ECG) changes:\n* ST elevation.\n* ST depression.\n* T wave inversion.\n* recent left bundle branch block.\n\n b- Troponin T elevation.\n\n 2-The CKD patient with or without dialysis with no previous history of ACS.\n\nExclusion Criteria:\n\n1. Patients who were diagnosed with primary hyperparathyroidism.\n2. Acute Kidney injury (AKI) which is defined as any of the following:(KDIGO2012)\n\n * Increase in S.Cr by ≥ 0.3 mg/dl (≥ 26.5 μmol/l) within 48hours; or\n * Increase in S.Cr to ≥ 1.5 times baseline, which is known or presumed to have occurred within the prior 7 days;or\n * Urine volume \\<0.5 ml/kg/h for 6 hours'}, 'identificationModule': {'nctId': 'NCT05134220', 'briefTitle': 'Electrolytes in Chronic Kidney Disease Patients With Acute Coronary Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Study of Serum Calcium and Phosphorus Level in Chronic Kidney Disease Patients With Acute Coronary Syndrome', 'orgStudyIdInfo': {'id': 'Electrolytes'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Chronic Kidney Disease (CKD) patients with acute coronary syndrome', 'description': 'The CKD patients with or without dialysis who admitted to coronary care unit with chest pain consistent with ACS with any of following features :\n\n1. Electrocardiogram (ECG) changes:\n\n * ST elevation.\n * ST depression.\n * T wave inversion.\n * recent left bundle branch block.\n2. Troponin elevation.', 'interventionNames': ['Diagnostic Test: Serum Calcium']}, {'label': 'Chronic Kidney Disease (CKD) patients without acute coronary syndrome', 'description': 'The CKD patient with or without dialysis with no previous history of ACS.', 'interventionNames': ['Diagnostic Test: Serum Calcium']}], 'interventions': [{'name': 'Serum Calcium', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['serum Phosphorus'], 'description': '* Serum calcium level.\n* Serum phosphorus level. will be measured to all study population', 'armGroupLabels': ['Chronic Kidney Disease (CKD) patients with acute coronary syndrome', 'Chronic Kidney Disease (CKD) patients without acute coronary syndrome']}]}, 'contactsLocationsModule': {'locations': [{'zip': '82524', 'city': 'Sohag', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Hassan A Elnoaman, Professor', 'role': 'CONTACT', 'email': 'president@sohag.edu.eg', 'phone': '0934570000'}], 'facility': 'Sohag university', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'Ahmed M YOUSEF, M.B.B.CH', 'role': 'CONTACT', 'email': 'ahmed011032@med.sohag.edu.eg', 'phone': '01067439846'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ahmed Mohamed Youssif', 'investigatorAffiliation': 'Sohag University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-07-05', 'type': 'RELEASE'}, {'date': '2024-02-21', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Ahmed Mohamed Youssif, Principal Investigator, Sohag University'}}}}