Ignite Creation Date:
2025-12-24 @ 9:36 PM
Ignite Modification Date:
2025-12-28 @ 10:39 PM
Study NCT ID:
NCT06151132
Status:
COMPLETED
Last Update Posted:
2023-11-30
First Post:
2023-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Atrial Fibrillation in the Community Settings
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004554', 'term': 'Electric Countershock'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 430}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-21', 'studyFirstSubmitDate': '2023-11-21', 'studyFirstSubmitQcDate': '2023-11-21', 'lastUpdatePostDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Gender', 'timeFrame': 'During procedure', 'description': 'Gender'}, {'measure': 'Age', 'timeFrame': 'During procedure', 'description': 'Age'}, {'measure': 'Body mass index', 'timeFrame': 'During procedure', 'description': 'weight in kilograms divided by the square of height in meters'}, {'measure': 'Heart Failure', 'timeFrame': 'Before procedure', 'description': 'Past history of chronic heart failure'}, {'measure': 'Arterial hypertension', 'timeFrame': 'Before procedure', 'description': 'Past history of arterial hypertension'}, {'measure': 'Coronary heart disease', 'timeFrame': 'Before procedure', 'description': 'Past history of coronary heart disease'}, {'measure': 'Diabetes mellitus', 'timeFrame': 'Before procedure', 'description': 'Past history of diabetes mellitus'}, {'measure': 'Type of arrhythmia', 'timeFrame': 'During procedure', 'description': 'Atrial fibrillation or atrial flutter'}, {'measure': 'Duration of arrhythmia', 'timeFrame': 'Before procedure', 'description': 'Duration of episode of arrhythmia before cardioversion'}, {'measure': 'Settings', 'timeFrame': 'During procedure', 'description': 'Whether procedure performed in inpatient or outpatient settings'}, {'measure': 'TEE', 'timeFrame': 'Before procedure', 'description': 'Whether transesophageal echocardiography was performed before procedure'}, {'measure': 'First procedure', 'timeFrame': 'Before procedure', 'description': 'Whether it is the first cardioversion in the patient'}, {'measure': 'Echo LVEF', 'timeFrame': 'During procedure', 'description': 'Left ventricular ejection fraction measured by echocardiography'}, {'measure': 'Echo LAVI', 'timeFrame': 'During procedure', 'description': 'Left atrium volume index measured by echocardiography'}], 'primaryOutcomes': [{'measure': 'Restoration of sinus rhythm', 'timeFrame': '1 day', 'description': 'Restoration of sinus rhythm during direct current cardioversion'}, {'measure': 'Maintenance in rhythm control strategy', 'timeFrame': '7 years', 'description': 'Maintenance in rhythm control strategy during treatment of atrial fibrillation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrial Arrhythmia', 'Cardiovascular Diseases']}, 'descriptionModule': {'briefSummary': 'Description of treatment of cardiovascular diseases in community settings in Russia', 'detailedDescription': 'The study will describe different treatment modalities used in management of cardiovascular diseases in community hospital in small town of Tarusa in Russia. This part of the study will focus on atrial fibrillation and its treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'People receiving treatment for atrial fibrillation in Tarusa hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all patients undergoing direct current cardioversion for atrial fibrillation or flutter\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT06151132', 'briefTitle': 'Treatment of Atrial Fibrillation in the Community Settings', 'organization': {'class': 'OTHER', 'fullName': 'ITMO University'}, 'officialTitle': 'Treatment of Atrial Fibrillation in the Community Settings', 'orgStudyIdInfo': {'id': 'ITMOU'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with atrial fibrillation', 'description': 'Direct current cardioversion', 'interventionNames': ['Procedure: Direct current cardioversion']}], 'interventions': [{'name': 'Direct current cardioversion', 'type': 'PROCEDURE', 'description': 'Direct current cardioversion to maintain sinus rhythm during rhythm control strategy', 'armGroupLabels': ['Patients with atrial fibrillation']}]}, 'ipdSharingStatementModule': {'infoTypes': ['ANALYTIC_CODE'], 'timeFrame': 'With the publication, for 5 years.', 'ipdSharing': 'YES', 'description': 'Deposition of all anonymized data in public repository.', 'accessCriteria': 'Public domain.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ITMO University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'researcher in Digital Public Health Technologies', 'investigatorFullName': 'Artemiy Okhotin', 'investigatorAffiliation': 'ITMO University'}}}}