Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-25 @ 8:50 PM
Study NCT ID:
NCT01253356
Status:
TERMINATED
Last Update Posted:
2012-01-06
First Post:
2010-12-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ACTIONS - Aortic Counterpulsation to Improve Outcomes in Noncardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'Only 1 patient recruited and deemed ineligible.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2012-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-01-05', 'studyFirstSubmitDate': '2010-12-02', 'studyFirstSubmitQcDate': '2010-12-02', 'lastUpdatePostDateStruct': {'date': '2012-01-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety', 'timeFrame': '30 days', 'description': 'Amputation, Clinically significant bleeding, Vascular complications'}], 'secondaryOutcomes': [{'measure': 'Efficacy', 'timeFrame': '30 days', 'description': 'A composite of the following:\n\nAll-cause mortality, Cardiovascular mortality, Hemorrhagic or ischemic stroke, New nonfatal myocardial infarction, New or worsening congestive heart failure, Hemodynamically significant arrhythmia requiring intervention'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Patients With History of Ischemic Heart Disease With LV Dysfunction Undergoing Noncardiac Surgery']}, 'descriptionModule': {'briefSummary': 'The use of the IABP, in addition to standard care, in high-risk cardiac patients undergoing major noncardiac surgery is feasible and may result in improved perioperative outcomes at 30 days compared with standard care alone, while maintaining acceptable safety with respect to vascular accesss-related complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients \\> 18 years with planned elective major abdominal, noncardiac thoracic, head and neck, vascular, or orthopedic surgery and guideline-treated iscehmic heart disease with left ventricular dysfunction (systolic ejection fraction \\< or = 30%)\n\nExclusion Criteria:\n\n* Unstable coronary syndromes Decompensated or NYHA Class IV heart failure Hemodynamic instability Cardiac biomarker instability Need for surgical procedure interfering with placement of IABP Cardiogenic shock Septic shock Contraindication to IABP use Clinical need for IABP ASA score \\> or = 5 Pregnancy Inability to provide informed consent'}, 'identificationModule': {'nctId': 'NCT01253356', 'acronym': 'ACTIONS', 'briefTitle': 'ACTIONS - Aortic Counterpulsation to Improve Outcomes in Noncardiac Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Datascope Corp.'}, 'officialTitle': 'A Multicenter, Randomized, Controlled Pilot Study of Intra-Aortic Balloon Counterpulsation to Prevent Perioperative Cardiac Events in High-Risk Cardiac Patients Undergoing Noncardiac Surgery', 'orgStudyIdInfo': {'id': 'P-00002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'No IABP', 'description': 'Standard of care and no IABP'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intra-Aortic Balloon Pump (IABP)', 'description': 'Standard of care, IABP inserted \\< or = 3 hours before noncardiac surgery, maintained for \\> or = 12-24 hours after surgery', 'interventionNames': ['Device: IABP']}], 'interventions': [{'name': 'IABP', 'type': 'DEVICE', 'description': 'Insertion of intra-aortic balloon \\< or = 3 hours before noncardiac surgery and maintained \\> or = 12-24 hours after surgery', 'armGroupLabels': ['Intra-Aortic Balloon Pump (IABP)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52803', 'city': 'Davenport', 'state': 'Iowa', 'country': 'United States', 'facility': 'Genesis Medical Center', 'geoPoint': {'lat': 41.52364, 'lon': -90.57764}}], 'overallOfficials': [{'name': 'Don Poldermans, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Erasmus Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Datascope Corp.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}