Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2026-01-03 @ 9:50 AM
Study NCT ID:
NCT03265067
Status:
COMPLETED
Last Update Posted:
2019-10-02
First Post:
2017-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Field Implementation of the autoRIC Device in STEMI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072657', 'term': 'ST Elevation Myocardial Infarction'}], 'ancestors': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Before and after phase study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1622}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-07-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-01', 'studyFirstSubmitDate': '2017-08-21', 'studyFirstSubmitQcDate': '2017-08-25', 'lastUpdatePostDateStruct': {'date': '2019-10-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '90-day MACCE', 'timeFrame': 'Within 90 days of PCI', 'description': 'Major adverse cardiovascular and cerebrovascular events (MACCE) in-hospital and within 90 days of PCI.'}], 'secondaryOutcomes': [{'measure': '30, 60 and 180-day MACCE', 'timeFrame': 'Within 30, 60 and 180 days of admission', 'description': 'MACCE within 30, 60 and 180 days post hospital admission'}, {'measure': 'LOS', 'timeFrame': 'Time from hospital admission to hospital discharge, up to 180 days of admission', 'description': 'Index hospitalization length of stay (LOS)'}, {'measure': 'Cardiovascular-related death', 'timeFrame': 'Time from hospital admission to hospital discharge, up to 180 days of admission', 'description': 'Death due to cardiovascular related events'}, {'measure': '30, 60, and 180-day cardiovascular-related readmission', 'timeFrame': '30, 60 and 180 days after index hospitalization', 'description': 'Hospital readmission within 30, 60, and 180 days of index hospitalization, due to cardiovascular events.'}, {'measure': 'Infarct size', 'timeFrame': 'Time from hospital admission to hospital discharge, up to 180 days of admission', 'description': 'Size of infarct as measured by peak troponin level during index event admission'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ST Elevation Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'This is a "before and after" observational study of a therapeutic strategy to treat patients with confirmed ST-segment myocardial infarction (STEMI) with remote ischemic conditioning (RIC) before undergoing primary percutaneous coronary intervention (PCI). RIC is the purposeful application of brief, intermittent cycles of limb occlusion by inflation/deflation of a pneumatic cuff. The autoRIC device is an automatic RIC delivery device (the autoRIC® Device; CellAegis Devices Inc, Toronto, ON) that has received clearance from Health Canada for this use under the direction of a health care professional. Paramedics in the Peel and Halton regional emergency services and the Emergency department (ED) staff of Brampton Civic Hospital and Mississauga Hospital will treat patients experiencing STEMI with autoRIC, and study data will be collected from existing patient records.\n\nThe \'before\' group will include up to 900 patients who were treated before autoRIC implementation in the services and hospitals. These patients would have had a STEMI and undergone PCI, but did not receive the autoRIC device. The \'after\' group will include up to 900 eligible patients who have had RIC treatment with the autoRIC device at the two participating sites following implementation in the services and hospitals.\n\nThe primary analyses will compare the short-term and long-term outcomes of eligible patients who have received completed primary PCI for STEMI in the time period before the implementation and following the implementation of this RIC strategy. In addition, a health economic analysis will be conducted to determine the cost-effectiveness of the therapeutic strategy to treat STEMI patients with RIC prior to PCI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age and older;\n* patients diagnosed with STEMI in the prehospital environment by responding paramedics from Peel Regional Paramedic Services or Halton Emergency Medical Service and transported to the PCI laboratory of Brampton Civic Hospital or Trillium Health Partners;\n* walk-in patients diagnosed with STEMI in the ED of either of these two facilities.\n\nExclusion Criteria:\n\n* left-bundle branch block;\n* Lymphedema on either arm\n* PICC Line on either arm\n* AV fistula or no palpable pulse on either arm;\n* patient has a known bleeding disorder or known abnormality of blood flow to the left arm;\n* patient has peripheral nerve injury, abnormal nerve supply, peripheral neuropathy or pre- existing traumatic injury to the limb to be treated (left-arm).'}, 'identificationModule': {'nctId': 'NCT03265067', 'acronym': 'FIRST', 'briefTitle': 'Field Implementation of the autoRIC Device in STEMI', 'organization': {'class': 'OTHER', 'fullName': 'William Osler Health System'}, 'officialTitle': 'Field Implementation of the autoRIC Device in STEMI', 'orgStudyIdInfo': {'id': '16-0008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': "'Before' group", 'description': 'Patients who underwent primary PCI for STEMI prior to implementation of the RIC protol. These patients were not treated with the autoRIC device prior to PCI.'}, {'type': 'EXPERIMENTAL', 'label': "'After' group", 'description': 'Patients who underwent primary PCI for STEMI after implementation of the RIC protocol. These patients were treated with the autoRIC device prior to PCI.', 'interventionNames': ['Device: autoRIC']}], 'interventions': [{'name': 'autoRIC', 'type': 'DEVICE', 'description': 'Application of the autoRIC device', 'armGroupLabels': ["'After' group"]}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L6R 3J7', 'city': 'Brampton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Brampton Civic Hospital', 'geoPoint': {'lat': 43.68341, 'lon': -79.76633}}, {'zip': 'L5B 1B8', 'city': 'Mississauga', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Mississauga Hospital', 'geoPoint': {'lat': 43.5789, 'lon': -79.6583}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'William Osler Health System', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sunnybrook Health Sciences Centre', 'class': 'OTHER'}, {'name': 'Trillium Health Centre', 'class': 'OTHER'}, {'name': 'Peel Regional Paramedic Service', 'class': 'UNKNOWN'}, {'name': 'Halton Region Paramedic Services', 'class': 'OTHER'}, {'name': 'CellAegis US, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Director', 'investigatorFullName': 'Dr. Sheldon Cheskes', 'investigatorAffiliation': 'Sunnybrook Health Sciences Centre'}}}}