Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-31 @ 10:54 PM
Study NCT ID:
NCT01461733
Status:
COMPLETED
Last Update Posted:
2014-09-15
First Post:
2010-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Atrial Fibrillation Without Hemodynamic Instability in the Intensive Care Unit
Sponsor:
Organization:
Raw JSON
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Average duration of ICU stay is 7 days.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Amiodarone', 'description': 'standard dose amiodarone'}, {'id': 'FG001', 'title': 'Placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Amiodarone', 'description': 'standard dose amiodarone\n\namiodarone: standard dose amiodarone'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo: placebo delivered blinded'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70', 'spread': '17', 'groupId': 'BG000'}, {'value': '61', 'spread': '17', 'groupId': 'BG001'}, {'value': '65', 'spread': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-09', 'studyFirstSubmitDate': '2010-08-19', 'resultsFirstSubmitDate': '2014-09-09', 'studyFirstSubmitQcDate': '2011-10-27', 'lastUpdatePostDateStruct': {'date': '2014-09-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-09-09', 'studyFirstPostDateStruct': {'date': '2011-10-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Conversion From Atrial Fibrillation to Sinus Rhythm', 'timeFrame': 'From randomization to conversion or ICU discharge up to 100 months.', 'description': 'Conversion rates measured during ICU stay only. Average duration of ICU stay is 7 days.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['atrial fibrillation', 'amiodarone'], 'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'Atrial fibrillation (AF) is an abnormal heart rhythm that is common among patients who are admitted to an intensive care unit (ICU) of a hospital. It is usually a transient occurrence that resolves as the patient recovers from their underlying condition. However, patients who develop AF can present with a very rapid heart rate that in some cases can put stress on the heart which can lead to life threatening heart attacks, low blood pressure or breathing problems. Not all patients with AF will have unstable heart function but those who have rapid heart rates can worsen quickly. The goals of treatment for AF with a rapid heart rate but no unstable heart function are two fold. Patients can be treated by controlling the heart rate and/or by attempting to convert the AF to a normal heart rhythm. The heart rate can be controlled by medication and the AF can be converted by either electrical cardioversion (an electric shock that jump-starts the heart) or medication. Currently it is unknown if the goal of treatment should be to simply control the heart rate and wait for the patient to spontaneously convert to a normal heart rhythm or convert the AF with medication for patients who only have the rapid heart rate.\n\nThe objective of this project is to conduct a pilot study to determine if it would be feasible to conduct a larger definitive trial that would answer the following question: Should the goal of treatment be to control the rapid heart rate or resolve the abnormal heart rhythm in patients with AF who have a rapid heart rate without unstable heart function.', 'detailedDescription': 'see above'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* new onset afib\n\nExclusion Criteria:\n\n* hemodynamically unstable'}, 'identificationModule': {'nctId': 'NCT01461733', 'acronym': 'AFIB', 'briefTitle': 'Atrial Fibrillation Without Hemodynamic Instability in the Intensive Care Unit', 'organization': {'class': 'OTHER', 'fullName': 'Ottawa Hospital Research Institute'}, 'officialTitle': 'Atrial Fibrillation WITHOUT Hemodynamic Stability', 'orgStudyIdInfo': {'id': 'NA5936 Heart and Stroke'}, 'secondaryIdInfos': [{'id': 'OHREB Protocol # 2006430-01', 'type': 'OTHER_GRANT', 'domain': 'heart and stroke foundation of ON'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'amiodarone', 'description': 'standard dose amiodarone', 'interventionNames': ['Drug: amiodarone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'amiodarone', 'type': 'DRUG', 'otherNames': ['non applicable'], 'description': 'standard dose amiodarone', 'armGroupLabels': ['amiodarone']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'placebo delivered blinded', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Salmaan Kanji, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ottawa Hospital Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ottawa Hospital Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Heart and Stroke Foundation of Ontario', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'S. Kanji', 'investigatorAffiliation': 'Ottawa Hospital Research Institute'}}}}