Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2025-12-25 @ 8:11 PM
Study NCT ID:
NCT04527835
Status:
UNKNOWN
Last Update Posted:
2020-10-08
First Post:
2020-08-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Presentation, Clinical Course and Patterns of Myocardial Damage Due to Viral Myocarditis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2021-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-06', 'studyFirstSubmitDate': '2020-08-23', 'studyFirstSubmitQcDate': '2020-08-23', 'lastUpdatePostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine the pattern of myocarditis in hospitalized patients with acute HF within the last 3 months', 'timeFrame': '6 months', 'description': 'All patients admitted with symptoms , signs and echocardiographic finding suggesting myocarditis within 3 months from start of the symptoms. as acute heart failure, arrhythmias, typical chest pain with ST segment deviation in ECG . dilated cardiomyopathy associated with normal Coronary Angiography, history of upper respiratory tract infection within the last 3 months. All will be investigated for determine the pattern of viral myocarditis in those patients'}], 'secondaryOutcomes': [{'measure': 'determination of the caustive organism', 'timeFrame': '6 months', 'description': '1\\. Determine the pattern of broad spectrum cardiotropic viruses in patients with acute HF within the last 3 months. These viruses like enteroviruses, adenoviruses and parvo B19 virus, HBV, HCV and Covid 19 virus due to its increased prevelance nowadays.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Viral Myocarditis']}, 'descriptionModule': {'briefSummary': 'Presentation, Clinical Course and Patterns of Myocardial Damage due to Viral Myocarditis', 'detailedDescription': '1. Determine the pattern of myocarditis in hospitalized patients with acute HF within the last 3 months.\n2. Determine the pattern of broad spectrum cardiotropic viruses in patients with acute HF within the last 3 months. These viruses like enteroviruses, adenoviruses and parvo B19 virus, HBV, HCV and Covid 19 virus due to its increased prevelance nowadays.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients complained of symptoms of moderate to severe heart disease including atypical chest pain, fatigue, reduced physical capacity, recently occurring cardiac arrhythmia, and/or dyspnea on exertion suggesting myocardial inflammation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: All patients admitted with symptoms , signs and echocardiographic finding suggesting myocarditis within 3 months from start of the symptoms. as acute heart failure, arrhythmias, typical chest pain with ST segment deviation in ECG . dilated cardiomyopathy associated with normal Coronary Angiography, history of upper respiratory tract infection within the last 3 months.\n\nExclusion Criteria:\n\n1. Patients with significant coronary artery disease.\n2. Patient with family history suggesting familial DCMP\n3. Critically ill patients.\n4. Patients who refuse to do coronary angiography . .\n5. Patients with severe valvular heart disease.\n6. Pregnant women\n7. Patients with raised renal chemistry.\n8. Echocardiographic finding showing LVEDD more than 6.5cm'}, 'identificationModule': {'nctId': 'NCT04527835', 'briefTitle': 'Presentation, Clinical Course and Patterns of Myocardial Damage Due to Viral Myocarditis', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Presentation, Clinical Course and Patterns of Myocardial Damage Due to Viral Myocarditis', 'orgStudyIdInfo': {'id': 'Viral myocarditis'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients suspected for viral myocarditis', 'description': 'All patients admitted with unexplained heart failure in the last 3 months will be investigated for viral myocarditis by the use of 12 lead ECG, echocardiography, Cardiac MRI , coronary angiography, Endomyocardial biopsy ( optional ), serological tests including ELIZA,Extraction of nucleic acid, Determination of viral genome by using PCR., Quantitative real-time PCR to assess viral load, Immunohistochemistry analysis of EMB.', 'interventionNames': ['Diagnostic Test: ELIZA, Extraction of nucleic acid ,Determination of viral genome by using PCR, Quantitative real-time PCR to assess viral load ,Immunohistochemistry analysis of EMB.']}], 'interventions': [{'name': 'ELIZA, Extraction of nucleic acid ,Determination of viral genome by using PCR, Quantitative real-time PCR to assess viral load ,Immunohistochemistry analysis of EMB.', 'type': 'DIAGNOSTIC_TEST', 'description': 'ELIZA, Extraction of nucleic acid ,Determination of viral genome by using PCR, Quantitative real-time PCR to assess viral load ,Immunohistochemistry analysis of EMB.', 'armGroupLabels': ['patients suspected for viral myocarditis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23123', 'city': 'Asyut', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Shery Asaad, resident', 'role': 'CONTACT', 'email': "drshosho31'@yahoo.com", 'phone': '01270992244'}, {'name': 'Ayman khairy, assistant professor', 'role': 'CONTACT', 'email': 'Ayman.hassan@aun.edu.eg', 'phone': '01094438055'}], 'facility': 'Shery Refaat Asaad', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Shery Asaad, Resident', 'role': 'CONTACT', 'email': 'drshosho31@yahoo.com', 'phone': '01270992244'}, {'name': 'Amr yousif, professor', 'role': 'CONTACT', 'email': 'amryoussef111@aun.edu.eg', 'phone': '01027355511'}], 'overallOfficials': [{'name': 'Ayman khairy, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assiut University'}, {'name': 'Mohamed El Mokhtar, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assiut University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Shery Refaat Asaad', 'investigatorAffiliation': 'Assiut University'}}}}