Ignite Creation Date:
2025-12-24 @ 4:48 PM
Ignite Modification Date:
2025-12-30 @ 12:55 AM
Study NCT ID:
NCT01563250
Status:
COMPLETED
Last Update Posted:
2013-04-04
First Post:
2011-06-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving the Management of Acute Coronary Syndromes in the Emergency Department
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 705}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-03', 'studyFirstSubmitDate': '2011-06-09', 'studyFirstSubmitQcDate': '2012-03-23', 'lastUpdatePostDateStruct': {'date': '2013-04-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ED length of stay', 'timeFrame': 'Average of 3 hours stay in the Emergency Department', 'description': 'From patient check-in time to patient admit or discharge time'}], 'secondaryOutcomes': [{'measure': 'Mortality rate of admitted patients', 'timeFrame': 'During hospital admission and at 30 days', 'description': 'Average hospital stay 3 days.'}, {'measure': 'Hospital Admission Rate', 'timeFrame': 'Baseline', 'description': 'Observing the rate at which physicians admit patients to the hospital.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acute Coronary Syndrome', 'Cardiac Biomarkers', 'point of care testing'], 'conditions': ['Acute Coronary Syndrome']}, 'referencesModule': {'references': [{'pmid': '20825823', 'type': 'BACKGROUND', 'citation': 'Birkhahn RH, Haines E, Wen W, Reddy L, Briggs WM, Datillo PA. Estimating the clinical impact of bringing a multimarker cardiac panel to the bedside in the ED. Am J Emerg Med. 2011 Mar;29(3):304-8. doi: 10.1016/j.ajem.2009.12.007. Epub 2010 Apr 2.'}]}, 'descriptionModule': {'briefSummary': 'By using a Rapid Cardiac Evaluation (RACE) pathway in the Emergency Department (ED), the investigators can effectively reduce ED wait times and ED length of stay by decreasing overall hospital admissions and telemetry admissions. In addition, the investigators hypothesize a decrease in mortality of those patients admitted for cardiac evaluation by increasing the patient to health care provider ratio.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chief complaint of chest pain\n* 35 years old or greater\n\nExclusion Criteria:\n\n* ST elevation MI\n* New Left Bundle Branch Block\n* Admission regardless of test result\n* Leaving ED against medical advice'}, 'identificationModule': {'nctId': 'NCT01563250', 'acronym': 'RACE', 'briefTitle': 'Improving the Management of Acute Coronary Syndromes in the Emergency Department', 'organization': {'class': 'OTHER', 'fullName': 'Integrated Medical Research LLC'}, 'officialTitle': 'Improving the Management of Acute Coronary Syndromes in the Emergency Department Using a Rapid Acute Cardiac Evaluation Pathway', 'orgStudyIdInfo': {'id': 'IMR-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Core Laboratory', 'description': 'Patients receiving serial routinely available cardiac biomarker testing in a core laboratory setting using Troponin T. (Roche Centaur)'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Point of Care', 'description': 'Patients will receive the Point of Care testing intervention using serial cardiac biomarker testing at the bedside including myoglobin, Troponin I and CK-MB. (Triage Cardiac Panel, Alere)', 'interventionNames': ['Device: Point of Care testing']}], 'interventions': [{'name': 'Point of Care testing', 'type': 'DEVICE', 'otherNames': ['Triage Cardiac Panel by Alere'], 'description': 'The investigators will implement 6 months of randomized testing periods, 2 weeks each. During this 2 week block, cardiac biomarkers will be tested at the bedside in the ED using the Triage Cardiac Panel that will test for CK-MB, Myoglobin, and Troponin I.\n\nEach blood sample that is take for point of care testing will be saved. The plasma from the saved sample will be frozen and the sample will be sent to an off-site testing center for high sensitivity troponin testing.\n\nAll patients will be followed at the 30-day mark and those patients who are discharged home from the ED will be followed within 48 hours as well.', 'armGroupLabels': ['Point of Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11215', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'New York Methodist Hospital', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}], 'overallOfficials': [{'name': 'Bethany A Byrd, D.O.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York Presbyterian Brooklyn Methodist Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Integrated Medical Research LLC', 'class': 'OTHER'}, 'collaborators': [{'name': 'Alere San Diego', 'class': 'INDUSTRY'}, {'name': 'New York State Department of Health', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Robert Birkhahn, MD', 'investigatorAffiliation': 'Integrated Medical Research LLC'}}}}