Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2025-12-26 @ 3:15 AM
Study NCT ID:
NCT00178620
Status:
COMPLETED
Last Update Posted:
2023-09-06
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Pre-hospital Administration of Thrombolytic Therapy With Urgent Culprit Artery Revascularization
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C087896', 'term': 'reteplase'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'richard.w.smalling@uth.tmc.edu', 'phone': '713-500-6559', 'title': 'Dr. Richard W. Smalling', 'organization': 'The University of Texas Health Science Center at Houston'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Group A', 'description': 'Full dose, pre-hospital fibrinolysis followed by treatment in the coronary care unit', 'otherNumAtRisk': 37, 'otherNumAffected': 0, 'seriousNumAtRisk': 37, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group B', 'description': 'One-half dose pre-hospital reteplase followed by urgent PCI', 'otherNumAtRisk': 253, 'otherNumAffected': 0, 'seriousNumAtRisk': 253, 'seriousNumAffected': 9}, {'id': 'EG002', 'title': 'Group C', 'description': 'Fibrinolytic ineligible patients, treated with primary PCI at the STEMI center', 'otherNumAtRisk': 37, 'otherNumAffected': 0, 'seriousNumAtRisk': 37, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'Group D', 'description': 'Patients not transported by participating EMS units but were transferred in and treated with primary PCI at the STEMI center', 'otherNumAtRisk': 63, 'otherNumAffected': 0, 'seriousNumAtRisk': 63, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 253, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mortality at 30 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '253', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Full does, pre-hospital fibrinolysis followed by treatment in the coronary care unit.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'One-half dose pre-hospital reteplase followed by urgent PCI'}, {'id': 'OG002', 'title': 'Group C', 'description': 'Fibrinolytic ineligible patients who were treated with primary PCI at the STEMI center.'}, {'id': 'OG003', 'title': 'Group D', 'description': 'Patients not transported by participating EMS units transferred in and treated with primary PCI at the STEMI center.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 day', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Infarction Size as Measured by Cardiac Magnetic Resonance Imaging (MRI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Full does, pre-hospital fibrinolysis followed by treatment in the coronary care unit.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'One-half dose pre-hospital reteplase followed by urgent PCI'}, {'id': 'OG002', 'title': 'Group C', 'description': 'Fibrinolytic ineligible patients who were treated with primary PCI at the STEMI center.'}, {'id': 'OG003', 'title': 'Group D', 'description': 'Patients not transported by participating EMS units transferred in and treated with primary PCI at the STEMI center.'}], 'timeFrame': '1 year', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Reduction in Time From Onset of Pain to Reperfusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Full does, pre-hospital fibrinolysis followed by treatment in the coronary care unit.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'One-half dose pre-hospital reteplase followed by urgent PCI'}, {'id': 'OG002', 'title': 'Group C', 'description': 'Fibrinolytic ineligible patients who were treated with primary PCI at the STEMI center.'}, {'id': 'OG003', 'title': 'Group D', 'description': 'Patients not transported by participating EMS units transferred in and treated with primary PCI at the STEMI center.'}], 'timeFrame': '1 year', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Angiographic Documentation of Reperfusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Full does, pre-hospital fibrinolysis followed by treatment in the coronary care unit.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'One-half dose pre-hospital reteplase followed by urgent PCI'}, {'id': 'OG002', 'title': 'Group C', 'description': 'Fibrinolytic ineligible patients who were treated with primary PCI at the STEMI center.'}, {'id': 'OG003', 'title': 'Group D', 'description': 'Patients not transported by participating EMS units transferred in and treated with primary PCI at the STEMI center.'}], 'timeFrame': '1 year', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Electrocardiogram (ECG) ST Segment Elevation Recovery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Full does, pre-hospital fibrinolysis followed by treatment in the coronary care unit.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'One-half dose pre-hospital reteplase followed by urgent PCI'}, {'id': 'OG002', 'title': 'Group C', 'description': 'Fibrinolytic ineligible patients who were treated with primary PCI at the STEMI center.'}, {'id': 'OG003', 'title': 'Group D', 'description': 'Patients not transported by participating EMS units transferred in and treated with primary PCI at the STEMI center.'}], 'timeFrame': '1 year', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected for this outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group A', 'description': 'Full dose, pre-hospital fibrinolysis followed by treatment in the coronary care unit'}, {'id': 'FG001', 'title': 'Group B', 'description': 'One-half dose pre-hospital reteplase followed by urgent PCI'}, {'id': 'FG002', 'title': 'Group C', 'description': 'Fibrinolytic ineligible patients, treated with primary PCI at the STEMI center'}, {'id': 'FG003', 'title': 'Group D', 'description': 'Patients not transported by participating EMS units but were transferred in and treated with primary PCI at the STEMI center'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '253'}, {'groupId': 'FG002', 'numSubjects': '37'}, {'groupId': 'FG003', 'numSubjects': '63'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '253'}, {'groupId': 'FG002', 'numSubjects': '37'}, {'groupId': 'FG003', 'numSubjects': '63'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'All ACS patients 18 years or older with documented STEMI on EKG, who presented within 6 hours of onset of sustained chest pain, and met all eligibility criteria, were enrolled in PATCAR after an informed consent was obtained.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}, {'value': '253', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}, {'value': '390', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Group A', 'description': 'Full dose, pre-hospital fibrinolysis followed by treatment in the coronary care unit.'}, {'id': 'BG001', 'title': 'Group B', 'description': 'One-half dose pre-hospital reteplase followed by urgent PCI'}, {'id': 'BG002', 'title': 'Group C', 'description': 'Fibrinolytic ineligible patients who were treated with primary PCI at the STEMI center.'}, {'id': 'BG003', 'title': 'Group D', 'description': 'Patients not transported by participating EMS units transferred in and treated with primary PCI at the STEMI center.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<=18 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}, {'title': 'Between 18 and 65 years', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '253', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}, {'value': '390', 'groupId': 'BG004'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '106', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '184', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}, {'value': '284', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Treatment Allocation by Group', 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '253', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}, {'value': '390', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 390}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-11', 'studyFirstSubmitDate': '2005-09-12', 'resultsFirstSubmitDate': '2015-06-22', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2023-09-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-08-11', 'studyFirstPostDateStruct': {'date': '2005-09-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality at 30 Days', 'timeFrame': '30 day'}], 'secondaryOutcomes': [{'measure': 'Infarction Size as Measured by Cardiac Magnetic Resonance Imaging (MRI)', 'timeFrame': '1 year'}, {'measure': 'Reduction in Time From Onset of Pain to Reperfusion', 'timeFrame': '1 year'}, {'measure': 'Angiographic Documentation of Reperfusion', 'timeFrame': '1 year'}, {'measure': 'Electrocardiogram (ECG) ST Segment Elevation Recovery', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Heart Disease', 'Heart Attack', 'Myocardial Infarction', 'Thrombolytic Therapy', 'Emergency Medicine'], 'conditions': ['Heart Disease', 'Myocardial Infarction', 'Acute Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'The PATCAR study has been designed to test the hypothesis that the strategy of pre-hospital use of a "clot busting" (thrombolytic) drug followed with emergent heart catheterization including stenting of the problematic coronary artery, will result in a lower mortality and reduced repeat heart attack rates.\n\nEarly identifying and treating heart attacks patients prior to the arriving at the hospital, in those patients who qualify for the "clot busting" drugs will lower the size of the heart attack damage. This smaller heart attack will lead to fewer problems with less repeat heart attacks and death in the future.', 'detailedDescription': "To demonstrate feasibility of the project in a pilot trial we plan to enroll up to 500 patients to pre-hospital thrombolysis/clot busting followed by emergent catheterization and stenting of the problematic or culprit artery.\n\nThis will comprise an EMS system capable of performing pre-hospital ECGs followed by emergent transportation to a Level I Cardiovascular Center where the patients will be taken to urgent cardiac catheterization and emergent stenting of the culprit artery.\n\nPatients identified as having typical symptoms of acute MI and an ECG consistent with acute ST elevation MI will be screened in the field by paramedics or in the spoke hospitals by the ED attending physicians using the screening form. Verbal Consent will be obtained for receiving acute therapy for their MI as outlined in the protocol. After therapy is initiated in the field or at the spoke hospital, the patients will be transported as quickly as possible to the receiving Level I Cardiovascular Center (Hub Hospital). The ED personnel in the Level I Cardiovascular Center will have activated the Interventional Cardiovascular Team and the Cath Lab personnel after having received the initial qualifying transmitted ECG.\n\nOnce the patient arrives, informed consent will be obtained by the ED investigator and/or in-house Cardiology fellow for enrollment in the PATCAR Trial. Thrombolytic ineligible patients will also be collect for this study and also go directly to the Cath Lab for PCI. Study coordinators will enter the data into the Case Report Forms and forward the completed forms to Westat-ALA for data capture in the database. In addition to the qualifying ECG, ECG's will be obtained at hospital discharge/transfer. All patients will follow the current standard of care for STEMI/heart attacks patients. Patients will have a Cardiac MRI done on day 3 or 5 of their hospital stay, to measure the size and amount of damage the heart suffered as a result of their Heart attack."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Ischemic discomfort (squeezing, crushing, or pressure, sub-sternal, unrelated to breathing or movement), epigastric discomfort or pre-syncopal symptoms with diaphoresis, lasting \\> 30 minutes.\n2. ST elevation \\> 0.1 mV in 2 or more contiguous limb leads or \\> 0.2 mV in 2 or more contiguous pre-cordial leads.\n3. Less than 6 hours after onset of sustained chest pain.\n4. Age 18 years or older.\n\nExclusion Criteria:\n\n1. Chest pain described as ripping or tearing, radiating to the back and/or down the leg, and/or systolic blood pressure \\> 15 mmHg difference in each arm.\n2. Suspected cocaine or amphetamine use within previous 3 days.\n3. Known or suspected pregnancy.\n4. Cardiac arrest requiring intubation.\n5. Cardiac arrest requiring greater than 20 minutes CPR.\n6. Coronary intervention (PTCA/stent/CABG) within previous 4 weeks.'}, 'identificationModule': {'nctId': 'NCT00178620', 'acronym': 'PATCAR', 'briefTitle': 'Pre-hospital Administration of Thrombolytic Therapy With Urgent Culprit Artery Revascularization', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'PATCAR Pilot Trial: A Phase 4 Study, Pre-hospital Administration of Thrombolytic Therapy With Urgent Culprit Artery Revascularization', 'orgStudyIdInfo': {'id': 'PATCAR Pilot Trial HSC 03-021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A: Full dose pre-hospital fibrinolysis', 'description': 'Patients transported by participating EMS units and that were fibrinolytic eligible and treated with full dose, pre-hospital fibrinolysis with reteplase (treated in the ambulance with 10 units reteplase and randomized to a second 10-unit dose of reteplase).', 'interventionNames': ['Drug: Reteplase 10 Units (U) plus a second dose of reteplase 10 U']}, {'type': 'EXPERIMENTAL', 'label': 'Group B: Half dose pre-hospital fibrinolysis followed by urgent PCI', 'description': 'Patients transported by participating EMS units and that were fibrinolytic eligible and treated with a half dose pre-hospital fibrinolysis with reteplase (treated in the ambulance with 10 units reteplase) and randomized to urgent catheterization with percutaneous coronary intervention (PCI).', 'interventionNames': ['Drug: Reteplase 10 U', 'Procedure: Urgent Percutaneous Coronary Intervention (PCI)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group C: Fibrinolytic ineligible patients receiving primary PCI', 'description': 'Patients transported by participating EMS units and that were fibrinolytic ineligible and treated with primary PCI alone and that were prospectively analyzed for comparison.', 'interventionNames': ['Procedure: Primary Percutaneous Coronary Intervention (PCI)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group D: Patients transferred in and treated with primary PCI', 'description': 'Patients not transported by participating EMS units but were transferred in and treated with primary PCI alone and that were prospectively analyzed for comparison.', 'interventionNames': ['Procedure: Primary Percutaneous Coronary Intervention (PCI)']}], 'interventions': [{'name': 'Reteplase 10 Units (U) plus a second dose of reteplase 10 U', 'type': 'DRUG', 'otherNames': ['Retavase'], 'description': 'Thrombolytic-clot busting drug Retavase IV Bolus, 10 U followed by a second 10U dose', 'armGroupLabels': ['Group A: Full dose pre-hospital fibrinolysis']}, {'name': 'Reteplase 10 U', 'type': 'DRUG', 'otherNames': ['Retavase'], 'description': 'Thrombolytic-clot busting drug Retavase IV Bolus in one 10U dose', 'armGroupLabels': ['Group B: Half dose pre-hospital fibrinolysis followed by urgent PCI']}, {'name': 'Urgent Percutaneous Coronary Intervention (PCI)', 'type': 'PROCEDURE', 'armGroupLabels': ['Group B: Half dose pre-hospital fibrinolysis followed by urgent PCI']}, {'name': 'Primary Percutaneous Coronary Intervention (PCI)', 'type': 'PROCEDURE', 'armGroupLabels': ['Group C: Fibrinolytic ineligible patients receiving primary PCI', 'Group D: Patients transferred in and treated with primary PCI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Memorial Hermann Hospital / The University of Texas HSC', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Richard W. Smalling, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor - Internal Medicine, Cardiology', 'investigatorFullName': 'Richard Smalling', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}