Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 11:22 PM
Study NCT ID:
NCT05391893
Status:
COMPLETED
Last Update Posted:
2024-12-27
First Post:
2021-09-23
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Effect of Oral and Intravenous Diltiazem Protocol for Emergency Department Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D001282', 'term': 'Atrial Flutter'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'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': 'D007260', 'term': 'Infusion Pumps'}], 'ancestors': [{'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D001187', 'term': 'Artificial Organs'}, {'id': 'D013523', 'term': 'Surgical Equipment'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rachelle.pichot@corewellhealth.org', 'phone': '(240)389-7340', 'title': 'Rachelle Pichot; Clinical Research Specialist', 'organization': 'SpectrumLakeland'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected for 24 hours following emergency room admittance.', 'eventGroups': [{'id': 'EG000', 'title': 'Diltiazem With Oral and Intravenous Treatment', 'description': 'Diltiazem 0.25mg/kg injection, give over 2 minutes, max dose 30mg. 15 minutes following Diltiazem Infusion administer oral Diltiazem 60mg IR Tablet, do not give if BP\\<100\n\nOral: Diltiazem 0.25mg/kg injection, give over 2 minutes, max dose 30mg', 'otherNumAtRisk': 177, 'deathsNumAtRisk': 177, 'otherNumAffected': 7, 'seriousNumAtRisk': 177, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Traditional Atrial Fibrillation With Rapid Ventricular Response', 'description': 'these patients will receive traditional treatments at provider discretion. To be included in teh study their initial heart rate must also be over 125, and they must receive at least one intravenous medication for atrial fibrillation with rapid ventricular response. This will be a heterogenous group of patients receiving digoxin, amiodarone, various beta-blockers, and intravenous diltiazem without oral diltiazem.\n\nIntravenous drug: these patients will receive traditional treatments at provider discretion. They must receive at least one intravenous medication for atrial fibrillation with rapid ventricular response. This will be a heterogenous group of patients receiving digoxin, amiodarone, various beta-blockers, and intravenous diltiazem without oral diltiazem.', 'otherNumAtRisk': 267, 'deathsNumAtRisk': 267, 'otherNumAffected': 17, 'seriousNumAtRisk': 267, 'deathsNumAffected': 1, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 267, 'numAffected': 17}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Admission Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Diltiazem With Oral and Intravenous Treatment', 'description': 'Diltiazem 0.25mg/kg injection, give over 2 minutes, max dose 30mg. 15 minutes following Diltiazem Infusion administer oral Diltiazem 60mg IR Tablet, do not give if BP\\<100\n\nOral: Diltiazem 0.25mg/kg injection, give over 2 minutes, max dose 30mg'}, {'id': 'OG001', 'title': 'Traditional Atrial Fibrillation With Rapid Ventricular Response', 'description': 'these patients will receive traditional treatments at provider discretion. To be included in teh study their initial heart rate must also be over 125, and they must receive at least one intravenous medication for atrial fibrillation with rapid ventricular response. This will be a heterogenous group of patients receiving digoxin, amiodarone, various beta-blockers, and intravenous diltiazem without oral diltiazem.\n\nIntravenous drug: these patients will receive traditional treatments at provider discretion. They must receive at least one intravenous medication for atrial fibrillation with rapid ventricular response. This will be a heterogenous group of patients receiving digoxin, amiodarone, various beta-blockers, and intravenous diltiazem without oral diltiazem.'}], 'classes': [{'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 days', 'description': 'This will compare rates of patients admitted between the protocol group and patients treated traditionally', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Treatment Success at 3 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '267', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Diltiazem With Oral and Intravenous Treatment', 'description': 'Diltiazem 0.25mg/kg injection, give over 2 minutes, max dose 30mg. 15 minutes following Diltiazem Infusion administer oral Diltiazem 60mg IR Tablet, do not give if BP\\<100\n\nOral: Diltiazem 0.25mg/kg injection, give over 2 minutes, max dose 30mg'}, {'id': 'OG001', 'title': 'Traditional Atrial Fibrillation With Rapid Ventricular Response', 'description': 'these patients will receive traditional treatments at provider discretion. To be included in teh study their initial heart rate must also be over 125, and they must receive at least one intravenous medication for atrial fibrillation with rapid ventricular response. This will be a heterogenous group of patients receiving digoxin, amiodarone, various beta-blockers, and intravenous diltiazem without oral diltiazem.\n\nIntravenous drug: these patients will receive traditional treatments at provider discretion. They must receive at least one intravenous medication for atrial fibrillation with rapid ventricular response. This will be a heterogenous group of patients receiving digoxin, amiodarone, various beta-blockers, and intravenous diltiazem without oral diltiazem.'}], 'classes': [{'categories': [{'measurements': [{'value': '150', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 hours', 'description': 'This will compare the total number of patients who in 3 hours from first medicine administration achieved heart rate less than 110 between the protocol and traditional treatment group', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rate of Hypotension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '267', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Diltiazem With Oral and Intravenous Treatment', 'description': 'Diltiazem 0.25mg/kg injection, give over 2 minutes, max dose 30mg. 15 minutes following Diltiazem Infusion administer oral Diltiazem 60mg IR Tablet, do not give if BP\\<100\n\nOral: Diltiazem 0.25mg/kg injection, give over 2 minutes, max dose 30mg'}, {'id': 'OG001', 'title': 'Traditional Atrial Fibrillation With Rapid Ventricular Response', 'description': 'these patients will receive traditional treatments at provider discretion. To be included in teh study their initial heart rate must also be over 125, and they must receive at least one intravenous medication for atrial fibrillation with rapid ventricular response. This will be a heterogenous group of patients receiving digoxin, amiodarone, various beta-blockers, and intravenous diltiazem without oral diltiazem.\n\nIntravenous drug: these patients will receive traditional treatments at provider discretion. They must receive at least one intravenous medication for atrial fibrillation with rapid ventricular response. This will be a heterogenous group of patients receiving digoxin, amiodarone, various beta-blockers, and intravenous diltiazem without oral diltiazem.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 day', 'description': 'rates of patients experiencing systolic blood pressure less than 90', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Diltiazem With Oral and Intravenous Treatment', 'description': 'Diltiazem 0.25mg/kg injection, give over 2 minutes, max dose 30mg. 15 minutes following Diltiazem Infusion administer oral Diltiazem 60mg IR Tablet, do not give if BP\\<100\n\nOral: Diltiazem 0.25mg/kg injection, give over 2 minutes, max dose 30mg'}, {'id': 'FG001', 'title': 'Traditional Atrial Fibrillation With Rapid Ventricular Response', 'description': 'these patients will receive traditional treatments at provider discretion. To be included in teh study their initial heart rate must also be over 125, and they must receive at least one intravenous medication for atrial fibrillation with rapid ventricular response. This will be a heterogenous group of patients receiving digoxin, amiodarone, various beta-blockers, and intravenous diltiazem without oral diltiazem.\n\nIntravenous drug: these patients will receive traditional treatments at provider discretion. They must receive at least one intravenous medication for atrial fibrillation with rapid ventricular response. This will be a heterogenous group of patients receiving digoxin, amiodarone, various beta-blockers, and intravenous diltiazem without oral diltiazem.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '177'}, {'groupId': 'FG001', 'numSubjects': '267'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '172'}, {'groupId': 'FG001', 'numSubjects': '249'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '18'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'BG000'}, {'value': '267', 'groupId': 'BG001'}, {'value': '444', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Diltiazem With Oral and Intravenous Treatment', 'description': 'Diltiazem 0.25mg/kg injection, give over 2 minutes, max dose 30mg. 15 minutes following Diltiazem Infusion administer oral Diltiazem 60mg IR Tablet, do not give if BP\\<100\n\nOral: Diltiazem 0.25mg/kg injection, give over 2 minutes, max dose 30mg'}, {'id': 'BG001', 'title': 'Traditional Atrial Fibrillation With Rapid Ventricular Response', 'description': 'these patients will receive traditional treatments at provider discretion. To be included in teh study their initial heart rate must also be over 125, and they must receive at least one intravenous medication for atrial fibrillation with rapid ventricular response. This will be a heterogenous group of patients receiving digoxin, amiodarone, various beta-blockers, and intravenous diltiazem without oral diltiazem.\n\nIntravenous drug: these patients will receive traditional treatments at provider discretion. They must receive at least one intravenous medication for atrial fibrillation with rapid ventricular response. This will be a heterogenous group of patients receiving digoxin, amiodarone, various beta-blockers, and intravenous diltiazem without oral diltiazem.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.1', 'spread': '13.3', 'groupId': 'BG000'}, {'value': '71', 'spread': '12.7', 'groupId': 'BG001'}, {'value': '70.05', 'spread': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '138', 'groupId': 'BG001'}, {'value': '240', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '157', 'groupId': 'BG000'}, {'value': '230', 'groupId': 'BG001'}, {'value': '387', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '177', 'groupId': 'BG000'}, {'value': '267', 'groupId': 'BG001'}, {'value': '444', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-12-03', 'size': 246415, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-12-03T11:57', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A treatment protocol using oral and IV diltiazem has been implemented. We will compare admission rates, time to heart rate control, and hypotension between the protocol group and patients receiving traditional treatments for atrial fibrillation with rapid ventricular response'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 444}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-03', 'studyFirstSubmitDate': '2021-09-23', 'resultsFirstSubmitDate': '2024-12-03', 'studyFirstSubmitQcDate': '2022-05-21', 'lastUpdatePostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-12-03', 'studyFirstPostDateStruct': {'date': '2022-05-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Admission Rate', 'timeFrame': '1 days', 'description': 'This will compare rates of patients admitted between the protocol group and patients treated traditionally'}, {'measure': 'Treatment Success at 3 Hours', 'timeFrame': '3 hours', 'description': 'This will compare the total number of patients who in 3 hours from first medicine administration achieved heart rate less than 110 between the protocol and traditional treatment group'}], 'secondaryOutcomes': [{'measure': 'Rate of Hypotension', 'timeFrame': '1 day', 'description': 'rates of patients experiencing systolic blood pressure less than 90'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation', 'Atrial Flutter']}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to reduce hospital admission and decrease time to disposition through establishing an effective treatment protocol for AF and Atrial Flutter in the Emergency Department of Spectrum Health Lakeland. Secondary outcome is to measure if oral diltiazem is an effective HR controlling agent in AF RVR and Flutter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Heart rate \\>125\n* Systolic BP\\>110\n* Atrial Fibrillation/Flutter confirmed on ECG.\n* Meets observation unit requirements (performs certain ADL's (acts of daily living)\n* Age\\>18.\n\nExclusion Criteria:\n\n* Wolf-Parkinson-White syndrome\n* ST Elevation Myocardial Infarction\n* Pregnant\n* Clinical diagnosis of Sepsis,\n* Decompensated HF\n* allergy to Diltiazem\n* provider discretion\n* clinical need for cardioversion"}, 'identificationModule': {'nctId': 'NCT05391893', 'briefTitle': 'Effect of Oral and Intravenous Diltiazem Protocol for Emergency Department Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'Corewell Health South'}, 'officialTitle': 'Emergency Department Atrial Fibrillation Oral Diltiazem Observation Protocol', 'orgStudyIdInfo': {'id': 'EGME#03-2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Diltiazem with oral and intravenous treatment', 'description': 'Diltiazem 0.25mg/kg injection, give over 2 minutes, max dose 30mg. 15 minutes following Diltiazem Infusion administer oral Diltiazem 60mg IR Tablet, do not give if BP\\<100', 'interventionNames': ['Drug: Oral']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'traditional atrial fibrillation with rapid ventricular response', 'description': 'these patients will receive traditional treatments at provider discretion. To be included in teh study their initial heart rate must also be over 125, and they must receive at least one intravenous medication for atrial fibrillation with rapid ventricular response. This will be a heterogenous group of patients receiving digoxin, amiodarone, various beta-blockers, and intravenous diltiazem without oral diltiazem.', 'interventionNames': ['Drug: Intravenous drug']}], 'interventions': [{'name': 'Oral', 'type': 'DRUG', 'otherNames': ['these patients will receive oral and intravenous diltiazem'], 'description': 'Diltiazem 0.25mg/kg injection, give over 2 minutes, max dose 30mg', 'armGroupLabels': ['Diltiazem with oral and intravenous treatment']}, {'name': 'Intravenous drug', 'type': 'DRUG', 'description': 'these patients will receive traditional treatments at provider discretion. They must receive at least one intravenous medication for atrial fibrillation with rapid ventricular response. This will be a heterogenous group of patients receiving digoxin, amiodarone, various beta-blockers, and intravenous diltiazem without oral diltiazem.', 'armGroupLabels': ['traditional atrial fibrillation with rapid ventricular response']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49085', 'city': 'Saint Joseph', 'state': 'Michigan', 'country': 'United States', 'facility': 'Matthew Hysell', 'geoPoint': {'lat': 42.10976, 'lon': -86.48002}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corewell Health South', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}