Ignite Creation Date:
2025-12-24 @ 5:01 PM
Ignite Modification Date:
2025-12-27 @ 6:28 AM
Study NCT ID:
NCT05040750
Status:
COMPLETED
Last Update Posted:
2024-10-08
First Post:
2021-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlation Between Cardiac Markers and Severity of COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 207}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2023-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-07', 'studyFirstSubmitDate': '2021-09-09', 'studyFirstSubmitQcDate': '2021-09-09', 'lastUpdatePostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'relation between cardiac markers and mortality rate in critically ill COVID 19 patients', 'timeFrame': '4 month', 'description': 'relate cardiac biomarkers to mortality rate'}], 'secondaryOutcomes': [{'measure': 'relation ship between cardiac and inflammatory and coagulation markers', 'timeFrame': '4 month', 'description': 'compare cardiac markers to inflammatory and coagulation laboratory findings'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiac Event']}, 'descriptionModule': {'briefSummary': 'By July 9, 2020, the global pandemic of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection had resulted in over 11.8 million confirmed cases and over 545000 deaths. Patients with a history of cardiovascular disease are especially vulnerable and have a bad prognosis. According to the findings, cardiac injury manifested by cardiac biomarker elevation is detected in a significant number of COVID-19 patients and is linked to poor outcomes and mortality. However, it is unclear how effective cardiac biomarkers are in COVID-19 prognosis and how to use these indicators.', 'detailedDescription': 'The pandemic of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has led to \\>11.8 million confirmed cases with \\>545000 deaths worldwide by July 9, 2020 Patients with preexisting cardiovascular conditions are particularly at risk and have poor prognosis data suggest that cardiac injury, manifested by cardiac biomarker elevation, is detected in a sizable of COVID-19 patients and is associated with adverse outcomes and increased mortality. However, how useful cardiac biomarkers are in COVID-19 prognosis and how to utilize these markers have not been well defined The study will include all moderate to severe COVID 19 patients admitted to ICU. Both genders within the age group 18-60 years were included. The primary outcome is the relation between cardiac markers and mortality rate in critically ill COVID 19 patients The secondary outcome is the relationship between cardiac and inflammatory and coagulation markers'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'all moderate to severe COVID 19 patients who were admitted to ICU', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all moderate to severe COVID 19 patients who were admitted to ICU.\n* Both genders\n* age group 18-60 years\n\nExclusion Criteria:\n\n* a refusal to participate in the study,\n* pregnant patients,\n* patients aged \\<18 or \\>60. years,\n* recent history of acute myocardial infarction (\\< 1 month before admission).'}, 'identificationModule': {'nctId': 'NCT05040750', 'briefTitle': 'Correlation Between Cardiac Markers and Severity of COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Correlation Between Cardiac Markers and Severity of COVID-19 in Egyptian Population', 'orgStudyIdInfo': {'id': 'FMASU R 150 / 2021'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'moderate to severe COVID 19 patients', 'description': 'moderate to severe COVID 19 patients admitted to ICU. Both genders within the age group 18-60 years were included. Diagnosis of COVID 19 was confirmed', 'interventionNames': ['Other: laboratory investigation']}], 'interventions': [{'name': 'laboratory investigation', 'type': 'OTHER', 'description': 'observe the relation between cardiac markers and mortality rate in critically ill COVID 19 patients', 'armGroupLabels': ['moderate to severe COVID 19 patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69711', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Fathy Tash, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ain Shams University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor of Anaesthesia', 'investigatorFullName': 'Rania Maher Hussien, MD', 'investigatorAffiliation': 'Ain Shams University'}}}}