Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-02-23 @ 9:59 AM
Study NCT ID:
NCT01655433
Status:
TERMINATED
Last Update Posted:
2014-07-25
First Post:
2012-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Ultrafast Hypothermia Before Reperfusion in STEMI Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007035', 'term': 'Hypothermia'}], 'ancestors': [{'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'whyStopped': 'Sponsor business decision, not safety related', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-24', 'studyFirstSubmitDate': '2012-07-30', 'studyFirstSubmitQcDate': '2012-07-30', 'lastUpdatePostDateStruct': {'date': '2014-07-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite of new-onset SAEs', 'timeFrame': '30 days', 'description': 'Composite of new-onset serious adverse events, specifically death, ischemia driven target vessel revascularization (TVR), recurrent MI, pneumonia, sepsis, ventricular tachycardia or fibrillation requiring cardioversion, renal failure, peritonitis and significant bleeding.'}], 'secondaryOutcomes': [{'measure': 'MACE rate', 'timeFrame': '30 days', 'description': 'MACE (cardiac related mortality, recurrent MI, or ischemia driven target vessel revascularization (PCI or CABG) at 30 days'}, {'measure': 'All cause mortality', 'timeFrame': '6 months', 'description': 'All cause mortality through 6 months'}, {'measure': 'Myocardial infarct size', 'timeFrame': '3 days', 'description': 'Myocardial infarct size at 3 days post-procedure'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ST-elevation MI', 'Hypothermia'], 'conditions': ['ST-elevation MI', 'Hypothermia']}, 'referencesModule': {'references': [{'pmid': '25699687', 'type': 'DERIVED', 'citation': 'Nichol G, Strickland W, Shavelle D, Maehara A, Ben-Yehuda O, Genereux P, Dressler O, Parvataneni R, Nichols M, McPherson J, Barbeau G, Laddu A, Elrod JA, Tully GW, Ivanhoe R, Stone GW; VELOCITY Investigators. Prospective, multicenter, randomized, controlled pilot trial of peritoneal hypothermia in patients with ST-segment- elevation myocardial infarction. Circ Cardiovasc Interv. 2015 Mar;8(3):e001965. doi: 10.1161/CIRCINTERVENTIONS.114.001965. Epub 2015 Feb 19.'}]}, 'descriptionModule': {'briefSummary': 'This study will look at the safety of treating patients with heart attack with mild hypothermia induced using a system of automated peritoneal lavage. The hypothesis is that the Velomedix Automated Peritoneal Lavage System can treat patients with heart attack safely and with adequate performance.', 'detailedDescription': 'The study aims to determine the safety and feasibility of using the Velomedix Automated Peritoneal Lavage System to treat patients with STEMI using therapeutic hypothermia. Patients will undergo cooling, maintenance and rewarming and applicable data will be gathered on device performance and patient safety. Patient temperature and vital signs will be monitored in addition to various laboratory values. Adverse event reporting will take place at multiple time intervals and follow-up will continue out to 6-months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical symptoms consistent with acute STEMI lasting at least 30 minutes\n* STEMI with ST-Elevation of ≥2 mm in two or more contiguous ECG leads\n* Patient eligible for PCI\n\nExclusion Criteria:\n\n* Cardiac arrest with return of spontaneous circulation\n* Known prior history of MI\n* Known history of severe COPD requiring supplemental home oxygen\n* Patient experiencing intractable cardiogenic shock, or requiring immediate placement of a mechanical cardiac assist device\n* Known severe anemia or abnormal platelet count\n* Known significant renal insufficiency\n* Known contraindication for MRI\n* Known contraindications to hypothermia, such as temperature-sensitive hematological dyscrasias or vasospastic disorders'}, 'identificationModule': {'nctId': 'NCT01655433', 'acronym': 'VELOCITY', 'briefTitle': 'Evaluation of Ultrafast Hypothermia Before Reperfusion in STEMI Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Velomedix, Inc.'}, 'officialTitle': 'VELOCITY: Pilot Study to Evaluate Ultrafast Hypothermia Before Reperfusion in Patients With Acute ST-Elevation Myocardial Infarction', 'orgStudyIdInfo': {'id': 'VMXP-2490'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Therapeutic Hypothermia Treatment', 'interventionNames': ['Device: Velomedix APLS device']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'No Hypothermia Treatment', 'description': 'control group is no hypothermia treatment', 'interventionNames': ['Other: No Hypothermia Treatment']}], 'interventions': [{'name': 'Velomedix APLS device', 'type': 'DEVICE', 'description': 'Velomedix, Automated Peritoneal Lavage System', 'armGroupLabels': ['Therapeutic Hypothermia Treatment']}, {'name': 'No Hypothermia Treatment', 'type': 'OTHER', 'armGroupLabels': ['No Hypothermia Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Heart Center Research, LLC', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'LA County USC Hospital', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '30501', 'city': 'Gainesville', 'state': 'Georgia', 'country': 'United States', 'facility': 'Northeast Georgia Medical Center', 'geoPoint': {'lat': 34.29788, 'lon': -83.82407}}, {'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Ochsner Medical Center', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': 'VSR 4R2,', 'city': 'Victoria', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Victoria Heart Institute Foundation', 'geoPoint': {'lat': 48.4359, 'lon': -123.35155}}, {'zip': 'G1V 4G5', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Institut Universitaire de cardiologie et pneumologie de Québec (Hopital Laval)', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'overallOfficials': [{'name': 'Gregg Stone, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York Presbyterian Hospital / Columbia University Medical Center'}, {'name': 'Graham Nichol, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington, Harberview Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Velomedix, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}