Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-26 @ 2:02 AM
Study NCT ID:
NCT00764205
Status:
UNKNOWN
Last Update Posted:
2008-10-01
First Post:
2008-09-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Randomized Trial of Prehospital Tropin Levels in Acute Coronary Syndrome (ACS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}, {'id': 'D000072658', 'term': 'Non-ST Elevated Myocardial Infarction'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-09', 'completionDateStruct': {'date': '2010-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-09-30', 'studyFirstSubmitDate': '2008-09-30', 'studyFirstSubmitQcDate': '2008-09-30', 'lastUpdatePostDateStruct': {'date': '2008-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Decrease door-to-reperfusion time for patients with non-STEMI's by measuring troponin levels prior to hospital arrival", 'timeFrame': '3-4 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ACS', 'non STEMI', 'ECG troponin', 'iSTAT', 'Acute coronary syndrome without ST-segment elevation'], 'conditions': ['Acute Coronary Syndrome']}, 'descriptionModule': {'briefSummary': "This study randomizes patients seen by Redmond Medic One into a control arm and a study arm when they present with acute coronary syndrome and have non-contributory ECG's (i.e.non-STEMI). The control group is treated normally and delivered to the receiving hospital. The study group is treated normally as well, however troponin measurements are made using an i-STAT blood analyzer prior to hospital arrival. The results are presented to the receiving physician. Door-to-reperfusion time is monitored for both groups."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients seen and treated by Redmond Fire Department Medic One.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over years of age\n* ACS without ST-segment elevation\n* Patient being transported to one of two participating hospitals\n\nExclusion Criteria:\n\n* Less then 18 years of age.\n* Post cardiac arrest.\n* ACS with ST-segment elevation.'}, 'identificationModule': {'nctId': 'NCT00764205', 'briefTitle': 'Randomized Trial of Prehospital Tropin Levels in Acute Coronary Syndrome (ACS)', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Redmond Fire Department Medic One'}, 'officialTitle': 'Randomized Trial of Prehospital Troponin Assessment Using the i-STAT Blood Analyzer', 'orgStudyIdInfo': {'id': '20070224'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study Group', 'description': 'Troponin measured prior to hospital arrival'}, {'label': 'Control Group', 'description': 'Patients transported to hospital without troponin measurements enroute'}]}, 'contactsLocationsModule': {'locations': [{'zip': '98052', 'city': '-Mobile Units in King County-', 'state': 'Washington', 'country': 'United States', 'facility': 'Redmond Fire Department Medic One Units'}], 'overallOfficials': [{'name': 'James P Jordan, BS, MS, MICP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Redmond Fire Department Medic One'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Redmond Fire Department Medic One', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Medic One Foundation', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'James P. Jordan BS, MS, MICP', 'oldOrganization': 'Redmond Fire Deparment Medic One'}}}}