Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2025-12-29 @ 1:20 PM
Study NCT ID:
NCT00300495
Status:
TERMINATED
Last Update Posted:
2017-04-28
First Post:
2006-03-08
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Amiodarone Given Before Lung Surgery to Prevent Atrial Fibrillation After Lung Resection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], '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'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000638', 'term': 'Amiodarone'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D001572', 'term': 'Benzofurans'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mpkim@houstonmethodist.org', 'phone': '7134415177', 'title': 'Min Kim', 'organization': 'Houston Methodist Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 week prior to surgery and 30 days after surgery', 'eventGroups': [{'id': 'EG000', 'title': '1 - Amiodarone', 'description': 'Perioperative amiodarone\n\nAmiodarone: Perioperative orally administered\n\nPatients received 200 mg of amiodarone three times a day for one week prior to surgery and 200 mg twice a day for one week after the surgery', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '2 - Control', 'description': 'Control arm, standard care with no perioperative amiodarone\n\nControl arm, standard care: Control', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Post-operative Atrial Fibrillation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1 - Amiodarone', 'description': 'Perioperative amiodarone\n\nAmiodarone: Perioperative orally administered\n\nPatients received 200 mg of amiodarone three times a day for one week prior to surgery and 200 mg twice a day for one week after the surgery'}, {'id': 'OG001', 'title': '2 - Control', 'description': 'Control arm, standard care with no perioperative amiodarone\n\nControl arm, standard care: Control'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Number of patients with post-operative atrial fibrillation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Post-operative Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1 - Amiodarone', 'description': 'Perioperative amiodarone\n\nAmiodarone: Perioperative orally administered\n\nPatients received 200 mg of amiodarone three times a day for one week prior to surgery and 200 mg twice a day for one week after the surgery'}, {'id': 'OG001', 'title': '2 - Control', 'description': 'Control arm, standard care with no perioperative amiodarone\n\nControl arm, standard care: Control'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'spread': '2', 'groupId': 'OG000'}, {'value': '5', 'spread': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 week on average', 'description': 'Length of hospital stay after the operation', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '1 - Amiodarone', 'description': 'Perioperative amiodarone\n\nAmiodarone: Perioperative orally administered\n\nPatients received 200 mg of amiodarone three times a day for one week prior to surgery and 200 mg twice a day for one week after the surgery'}, {'id': 'FG001', 'title': '2 - Control', 'description': 'Control arm, standard care with no perioperative amiodarone\n\nControl arm, standard care: Control'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'One patient in the control group was excluded because, after patient was enrolled, patient had mediastinoscopy that showed more advanced disease. Thus, patient did not undergo lung resection. Therefore this patient was excluded from the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '1 - Amiodarone', 'description': 'Perioperative amiodarone\n\nAmiodarone: Perioperative orally administered'}, {'id': 'BG001', 'title': '2 - Control', 'description': 'Control arm, standard care with no perioperative amiodarone\n\nControl arm, standard care: Control'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age > 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'whyStopped': 'Unable to accrual total number of participants during study period.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2009-10-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-20', 'studyFirstSubmitDate': '2006-03-08', 'resultsFirstSubmitDate': '2017-03-20', 'studyFirstSubmitQcDate': '2006-03-08', 'lastUpdatePostDateStruct': {'date': '2017-04-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-03-20', 'studyFirstPostDateStruct': {'date': '2006-03-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-10-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Post-operative Atrial Fibrillation', 'timeFrame': '30 days', 'description': 'Number of patients with post-operative atrial fibrillation'}], 'secondaryOutcomes': [{'measure': 'Length of Post-operative Hospital Stay', 'timeFrame': '1 week on average', 'description': 'Length of hospital stay after the operation'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Atrial fibrillation', 'Lung cancer', 'Pulmonary resection', 'Post-operative complications'], 'conditions': ['Atrial Fibrillation', 'Lung Cancer']}, 'descriptionModule': {'briefSummary': 'Atrial fibrillation is a very common complication of pulmonary resection. Patients who develop atrial fibrillation require additional treatment and are more likely to stay in the hospital for longer period of time increasing the costs associated with the operation. We propose a randomized controlled trial to see if oral amiodarone given for one week before surgery can prevent atrial fibrillation after pulmonary resection. We plan to evaluate the incidence of atrial fibrillation in patients who received preoperative amiodarone and compare them to the incidence of atrial fibrillation in patients who did not received preoperative amiodarone.', 'detailedDescription': 'Atrial fibrillation is a very common complication of pulmonary resection. Patients who develop atrial fibrillation require additional treatment and are more likely to stay in the hospital for longer period of time increasing the costs associated with the operation.\n\nWe propose a study to see if oral amiodarone given for one week before surgery can prevent atrial fibrillation after pulmonary resection. We plan to evaluate the incidence of atrial fibrillation in patients who received preoperative amiodarone and compare them to the incidence of atrial fibrillation in patients who did not received preoperative amiodarone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Resectable lung nodule or mass\n\nExclusion Criteria:\n\n* Allergy to amiodarone\n* Currently taking amiodarone\n* Documented atrial fibrillation within past 12 months\n* Known pulmonary fibrosis\n* Known hepatic dysfunction\n* Thyroid disease\n* 2nd or 3rd degree heart block\n* Severe SA node disease\n* Bradycardia-induced syncope\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT00300495', 'briefTitle': 'Study of Amiodarone Given Before Lung Surgery to Prevent Atrial Fibrillation After Lung Resection', 'organization': {'class': 'OTHER', 'fullName': 'Beth Israel Deaconess Medical Center'}, 'officialTitle': 'Phase III Study of Preoperative Amiodarone for Prevention of Atrial Fibrillation After Lung Resection', 'orgStudyIdInfo': {'id': '2005P000376'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1 - Amiodarone', 'description': 'Perioperative amiodarone', 'interventionNames': ['Drug: Amiodarone']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2 - Control', 'description': 'Control arm, standard care with no perioperative amiodarone', 'interventionNames': ['Other: Control arm, standard care']}], 'interventions': [{'name': 'Amiodarone', 'type': 'DRUG', 'otherNames': ['Cordarone', 'Pacerone'], 'description': 'Perioperative orally administered', 'armGroupLabels': ['1 - Amiodarone']}, {'name': 'Control arm, standard care', 'type': 'OTHER', 'description': 'Control', 'armGroupLabels': ['2 - Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Malcolm M DeCamp, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beth Israel Deaconess Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beth Israel Deaconess Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Malcolm DeCamp', 'investigatorAffiliation': 'Beth Israel Deaconess Medical Center'}}}}