Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2026-02-22 @ 12:23 PM
Study NCT ID:
NCT02322892
Status:
COMPLETED
Last Update Posted:
2017-03-30
First Post:
2014-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Thiamine as an Adjunctive Therapy in Cardiac Surgery
Sponsor:
Organization:
Raw JSON
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Andersen', 'organization': 'Beth Israel Deaconess Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Control Arm', 'description': '50 mL normal saline solution\n\nNormal saline solution: 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)', 'otherNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Thiamine', 'description': '200 mg thiamine in 50 mL normal saline solution\n\nThiamine: 200 mg thiamine in 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)', 'otherNumAtRisk': 31, 'otherNumAffected': 0, 'seriousNumAtRisk': 31, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Lactate Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Arm', 'description': '50 mL normal saline solution\n\nNormal saline solution: 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)'}, {'id': 'OG001', 'title': 'Thiamine', 'description': '200 mg thiamine in 50 mL normal saline solution\n\nThiamine: 200 mg thiamine in 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1.7', 'upperLimit': '2.4'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.5', 'upperLimit': '2.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-surgery within 1 hour of arrival to the ICU', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intention to treat'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in Pyruvate Dehydrogenase (PDH) Enzyme Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Arm', 'description': '50 mL normal saline solution\n\nNormal saline solution: 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)'}, {'id': 'OG001', 'title': 'Thiamine', 'description': '200 mg thiamine in 50 mL normal saline solution\n\nThiamine: 200 mg thiamine in 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '84'}, {'value': '15', 'groupId': 'OG001', 'lowerLimit': '11', 'upperLimit': '37'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-surgery within 1 hour of arrival to the ICU', 'description': 'PDH activity will be measured in isolated peripheral blood mononuclear cells using a novel immunocapture and microplate-based method. Reported as relative change from before the surgery.', 'unitOfMeasure': 'Percent change from baseline', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patients With Post-operative Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Arm', 'description': '50 mL normal saline solution\n\nNormal saline solution: 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)'}, {'id': 'OG001', 'title': 'Thiamine', 'description': '200 mg thiamine in 50 mL normal saline solution\n\nThiamine: 200 mg thiamine in 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Until hospital discharge, limit 60 days', 'description': 'Atrial fibrillation, delirium, renal failure, stroke, myocardial infarction, acute respiratory distress syndrome, infection', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Arm', 'description': '50 mL normal saline solution\n\nNormal saline solution: 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)'}, {'id': 'OG001', 'title': 'Thiamine', 'description': '200 mg thiamine in 50 mL normal saline solution\n\nThiamine: 200 mg thiamine in 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)'}], 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '4.0'}, {'value': '2.4', 'groupId': 'OG001', 'lowerLimit': '1.1', 'upperLimit': '4.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Until hospital discharge, limit 60 days', 'description': 'Duration of intensive care unit stay', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Arm', 'description': '50 mL normal saline solution\n\nNormal saline solution: 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)'}, {'id': 'OG001', 'title': 'Thiamine', 'description': '200 mg thiamine in 50 mL normal saline solution\n\nThiamine: 200 mg thiamine in 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Until hospital discharge, limit 60 days', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Lactate Levels', 'timeFrame': 'Six hours after end of surgery surgery', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Pyruvate Dehydrogenase (PDH) Enzyme Activity', 'timeFrame': 'Six hours after end of surgery surgery', 'description': 'PDH activity will be measured in isolated peripheral blood mononuclear cells using a novel immunocapture and microplate-based method', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Time on Mechanical Ventilation', 'timeFrame': 'Limit 60 days', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Time on Vasopressors', 'timeFrame': 'Limit 60 days', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Global Oxygen Consumption (VO2)', 'timeFrame': 'From arrival to ICU to extubation, limit 6 hours', 'description': 'VO2 will be measured with a Compact Anesthesia monitor', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Cellular Oxygen Consumption', 'timeFrame': 'Post-surgery within 1 hour of arrival to the ICU', 'description': 'Cellular (peripheral blood mononuclear cells) oxygen consumption measured with the XFe24 Extracellular Flux Analyzers', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control Arm', 'description': '50 mL normal saline solution\n\nNormal saline solution: 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)'}, {'id': 'FG001', 'title': 'Thiamine', 'description': '200 mg thiamine in 50 mL normal saline solution\n\nThiamine: 200 mg thiamine in 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Number randomized', 'groupId': 'FG000', 'numSubjects': '35'}, {'comment': 'Number randomized', 'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Received placebo', 'groupId': 'FG000', 'numSubjects': '33'}, {'comment': 'Received thiamine', 'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Surgery cancelled', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Met exclusion criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '275 coronary artery bypass grafting patients screened between January and July 2015', 'preAssignmentDetails': '206 patients not included for various reasons. 5 patients were randomized, but never received the assigned treatment and was therefore not included in the pre-specified modified intend-to-treat analysis.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control Arm', 'description': '50 mL normal saline solution\n\nNormal saline solution: 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)'}, {'id': 'BG001', 'title': 'Thiamine', 'description': '200 mg thiamine in 50 mL normal saline solution\n\nThiamine: 200 mg thiamine in 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '73', 'groupId': 'BG000', 'lowerLimit': '68', 'upperLimit': '79'}, {'value': '71', 'groupId': 'BG001', 'lowerLimit': '67', 'upperLimit': '75'}, {'value': '72', 'groupId': 'BG002', 'lowerLimit': '67', 'upperLimit': '78'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '48', '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': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '63', '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': '33', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Modified intention to treat analysis'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-03', 'studyFirstSubmitDate': '2014-12-14', 'resultsFirstSubmitDate': '2016-04-07', 'studyFirstSubmitQcDate': '2014-12-22', 'lastUpdatePostDateStruct': {'date': '2017-03-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-03-03', 'studyFirstPostDateStruct': {'date': '2014-12-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Lactate Levels', 'timeFrame': 'Six hours after end of surgery surgery'}, {'measure': 'Pyruvate Dehydrogenase (PDH) Enzyme Activity', 'timeFrame': 'Six hours after end of surgery surgery', 'description': 'PDH activity will be measured in isolated peripheral blood mononuclear cells using a novel immunocapture and microplate-based method'}, {'measure': 'Time on Mechanical Ventilation', 'timeFrame': 'Limit 60 days'}, {'measure': 'Time on Vasopressors', 'timeFrame': 'Limit 60 days'}, {'measure': 'Global Oxygen Consumption (VO2)', 'timeFrame': 'From arrival to ICU to extubation, limit 6 hours', 'description': 'VO2 will be measured with a Compact Anesthesia monitor'}, {'measure': 'Cellular Oxygen Consumption', 'timeFrame': 'Post-surgery within 1 hour of arrival to the ICU', 'description': 'Cellular (peripheral blood mononuclear cells) oxygen consumption measured with the XFe24 Extracellular Flux Analyzers'}], 'primaryOutcomes': [{'measure': 'Lactate Levels', 'timeFrame': 'Post-surgery within 1 hour of arrival to the ICU'}], 'secondaryOutcomes': [{'measure': 'Percentage Change From Baseline in Pyruvate Dehydrogenase (PDH) Enzyme Activity', 'timeFrame': 'Post-surgery within 1 hour of arrival to the ICU', 'description': 'PDH activity will be measured in isolated peripheral blood mononuclear cells using a novel immunocapture and microplate-based method. Reported as relative change from before the surgery.'}, {'measure': 'Patients With Post-operative Complications', 'timeFrame': 'Until hospital discharge, limit 60 days', 'description': 'Atrial fibrillation, delirium, renal failure, stroke, myocardial infarction, acute respiratory distress syndrome, infection'}, {'measure': 'Length of Stay', 'timeFrame': 'Until hospital discharge, limit 60 days', 'description': 'Duration of intensive care unit stay'}, {'measure': 'Mortality', 'timeFrame': 'Until hospital discharge, limit 60 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Thiamine', 'Vitamin B1', 'Coronary artery bypass grafting', 'Cardiac surgery', 'Lactate', 'Pyruvate dehydrogenase'], 'conditions': ['Coronary Artery Bypass', 'Cardiac Surgical Procedures']}, 'referencesModule': {'references': [{'pmid': '27044557', 'type': 'DERIVED', 'citation': 'Andersen LW, Holmberg MJ, Berg KM, Chase M, Cocchi MN, Sulmonte C, Balkema J, MacDonald M, Montissol S, Senthilnathan V, Liu D, Khabbaz K, Lerner A, Novack V, Liu X, Donnino MW. Thiamine as an adjunctive therapy in cardiac surgery: a randomized, double-blind, placebo-controlled, phase II trial. Crit Care. 2016 Mar 14;20:92. doi: 10.1186/s13054-016-1245-1.'}]}, 'descriptionModule': {'briefSummary': "The main purpose of this pilot study is to test the effects of thiamine (vitamin B1) administration before and after major cardiac surgery. Half of patients will receive thiamine and the other half will receive placebo.\n\nThe investigators' main hypothesis is that thiamine will improve cellular oxygen consumption and lead to decreased levels of post-operative lactate levels and ultimately improved patient outcomes.", 'detailedDescription': "Over 230,000 patients in the United States undergo Coronary Artery Bypass Grafting (CABG) each year. While mortality is relatively low, morbidity remains substantial with a significant risk of prolonged time on mechanical ventilation, prolonged length of hospital and intensive care unit stay and many other complications. CABG causes a profound stress response and significant metabolic alterations occur, including a shift from aerobic to anaerobic metabolism, causing increased levels of pyruvate and lactate. Elevated lactate, a marker of anaerobic metabolism, is a common and significant finding in patients after CABG and is correlated with increased mortality and morbidity.\n\nAerobic metabolism occurs when pyruvate enters the mitochondria through pyruvate decarboxylation to acetyl-Coenzyme A, facilitated by the enzyme pyruvate dehydrogenase (PDH). Decreased PDH activity may cause a shift toward anaerobic metabolism and play a role in the changes seen in patients undergoing CABG. Thiamine (vitamin B1) is a key co-factor for PDH function and will increase activity even in non-deficient states. The investigators hypothesize that thiamine administration will increase PDH activity in patients undergoing CABG, leading to increased cellular oxygen consumption, as represented by decreased lactate levels after surgery, and ultimately improved clinical outcomes.\n\nIn order to test the investigators' hypothesis and to obtain data for a large-scale clinical trial evaluating relevant clinical endpoints, the investigators are conducting a randomized, double-blind, pilot trial of thiamine in high-risk patients undergoing CABG."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (≥ 21 years)\n* Coronary artery bypass grafting (CABG) with or without concomitant valve procedures\n* EuroSCORE II \\> 1.5%\n\nExclusion Criteria:\n\n* Current thiamine supplementation\n* Known allergy to thiamine\n* Competing indication for thiamine administration as judged by the clinical team (e.g., alcoholic)\n* Research-protected populations (pregnant women, prisoners, the intellectually disabled)\n* Emergent or salvage CABG (as defined by the Society of Thoracic Surgeons)\n* Off-pump surgery (i.e. surgery without cardiopulmonary bypass)'}, 'identificationModule': {'nctId': 'NCT02322892', 'briefTitle': 'Thiamine as an Adjunctive Therapy in Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Beth Israel Deaconess Medical Center'}, 'officialTitle': 'Thiamine as an Adjunctive Therapy in Cardiac Surgery', 'orgStudyIdInfo': {'id': '2014P000257'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control Arm', 'description': '50 mL normal saline solution', 'interventionNames': ['Drug: Normal saline solution']}, {'type': 'EXPERIMENTAL', 'label': 'Thiamine', 'description': '200 mg thiamine in 50 mL normal saline solution', 'interventionNames': ['Drug: Thiamine']}], 'interventions': [{'name': 'Thiamine', 'type': 'DRUG', 'otherNames': ['vitamin B1', 'Thiamin'], 'description': '200 mg thiamine in 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)', 'armGroupLabels': ['Thiamine']}, {'name': 'Normal saline solution', 'type': 'DRUG', 'description': '50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)', 'armGroupLabels': ['Control Arm']}]}, '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': 'Michael W Donnino, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beth Israel Deaconess Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beth Israel Deaconess Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Heart Association', 'class': 'OTHER'}, {'name': 'University of Aarhus', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Michael Donnino', 'investigatorAffiliation': 'Beth Israel Deaconess Medical Center'}}}}