Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2026-01-07 @ 9:22 PM
Study NCT ID:
NCT06490432
Status:
RECRUITING
Last Update Posted:
2024-08-07
First Post:
2024-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pattern of Cardiac Arrhythmia in Patients With MASLD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-07-31', 'releaseDate': '2025-07-13'}], 'estimatedResultsFirstSubmitDate': '2025-07-13'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004562', 'term': 'Electrocardiography'}], 'ancestors': [{'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004568', 'term': 'Electrodiagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-10-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-06', 'studyFirstSubmitDate': '2024-06-30', 'studyFirstSubmitQcDate': '2024-06-30', 'lastUpdatePostDateStruct': {'date': '2024-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac arrhythmia and MASLD patients', 'timeFrame': '1 year', 'description': 'Study metabolic dysfunction -assocatied steatotic liver disease'}, {'measure': 'Cardiac arrhythmia', 'timeFrame': '1 year', 'description': 'Study pattern of cardiac arrhythmia'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiac Arrhythmia', 'Metabolic Dysfunction Associated Steatotic Liver Disease']}, 'referencesModule': {'references': [{'pmid': '37907259', 'type': 'BACKGROUND', 'citation': 'Lee HH, Lee HA, Kim EJ, Kim HY, Kim HC, Ahn SH, Lee H, Kim SU. Metabolic dysfunction-associated steatotic liver disease and risk of cardiovascular disease. Gut. 2024 Feb 23;73(3):533-540. doi: 10.1136/gutjnl-2023-331003.'}]}, 'descriptionModule': {'briefSummary': 'Study the relationship between patients with MASLD and cardiac arrhythmia that could be occur in thos patients', 'detailedDescription': 'Study the cardiac arrhythmia that could be occur in patients suffering form metabolic dysfunction -assocatied steatotic liver disease and risk factors of them'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Study relationship between patients with metabolic dysfunction -assocatied steatotic liver disease and cardiac arrhythmia in those patients', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients aged 18years or older Patients with metabolic dysfunction -assocatied steatotic liver disease\n\nExclusion Criteria:\n\n* RHD Structural heart diseases Liver diseases other than MASLD'}, 'identificationModule': {'nctId': 'NCT06490432', 'briefTitle': 'Pattern of Cardiac Arrhythmia in Patients With MASLD', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Pattern of Cardiac Arrhythmia in Patients With Metabolic Dysfunction -Assocatied Steatotic Liver Disease in Sohag University Hospital.', 'orgStudyIdInfo': {'id': 'Soh-Med-24-06-04MS'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Transient elastography', 'type': 'DEVICE', 'otherNames': ['Echocardiograpy', 'ECG'], 'description': 'Device that measures stiffness of liver tissue'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'state': 'So', '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': 'Asmaa Rashwan Ahmed, doctor', 'role': 'CONTACT', 'email': 'asmarshwan5@gmail.com', 'phone': '01118523043'}, {'name': 'Usama Mohamed Abdalaal, Professor', 'role': 'CONTACT', 'phone': '+20 106 596 2094'}], 'overallOfficials': [{'name': 'Mohamed Ahmed Mostafa, Lecturer', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sohag University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Asmaa Rashwan Ahmed', 'investigatorAffiliation': 'Sohag University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-07-13', 'type': 'RELEASE'}, {'date': '2025-07-31', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Asmaa Rashwan Ahmed, Principal investigator, Sohag University'}}}}