Ignite Creation Date:
2025-12-24 @ 10:17 PM
Ignite Modification Date:
2026-04-15 @ 10:02 AM
Study NCT ID:
NCT03132935
Status:
COMPLETED
Last Update Posted:
2017-04-28
First Post:
2017-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Telemedical vs. Conventional Prehospital Care in Acute Coronary Syndromes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}, {'id': 'D000072657', 'term': 'ST Elevation 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': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 221}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2015-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-24', 'studyFirstSubmitDate': '2017-04-24', 'studyFirstSubmitQcDate': '2017-04-24', 'lastUpdatePostDateStruct': {'date': '2017-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': 'prehospital phase (0.5-2 hours)', 'description': 'respiratory / circulatory insufficiency, allergic reaction, cardiac arrest'}], 'secondaryOutcomes': [{'measure': 'Correct use of Aspirin', 'timeFrame': 'prehospital phase (0.5-2 hours)', 'description': 'Correct use of Aspirin based on current guidelines'}, {'measure': 'Correct use of unfractionated Heparin (UFH)', 'timeFrame': 'prehospital phase (0.5-2 hours)', 'description': 'Correct use of UFH based on current guidelines'}, {'measure': 'Correct use of Morphine', 'timeFrame': 'prehospital phase (0.5-2 hours)', 'description': 'Correct use of Morphine based on current guidelines'}, {'measure': 'Use of 12-lead-ECG', 'timeFrame': 'prehospital phase (0.5-2 hours)', 'description': 'Use of 12-lead-ECG after first medical contact'}, {'measure': 'Correct transport destination', 'timeFrame': 'prehospital phase (0.5-2 hours)', 'description': 'hospital with cath lab in ST-segment elevation myocardial infarction or high-risk Non-STEMI-ACS'}, {'measure': 'Correct use of oxygen', 'timeFrame': 'prehospital phase (0.5-2 hours)', 'description': 'Correct use of Morphine based on current guidelines'}, {'measure': 'Correct use of Glyceroltrinitrate', 'timeFrame': 'prehospital phase (0.5-2 hours)', 'description': 'Correct use of Glyceroltrinitrate based on current guidelines'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Non-STEMI Acute Coronary Syndrome', 'ST-segment elevation myocardial infarction', 'Telemedicine'], 'conditions': ['Acute Coronary Syndrome']}, 'descriptionModule': {'briefSummary': 'Telemedically supported paramedic care of acute coronary syndromes was compared to a historical control period of solely conventional on-scene physician care. Quality outcomes based on current guidelines were researched als well as time requirements in both groups.', 'detailedDescription': 'Telemedically supported paramedic care of acute coronary syndromes was compared to a historical control period of solely conventional on-scene physician care. Quality outcomes based on current guidelines were researched als well as time requirements in both groups. All data was collected prospectively for quality management purposes and analyzed retrospectively after ethical approval by the local ethics committee.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who called the emergency medical service and the paramedics suspect acute coronary syndrome.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: symptoms of acute coronary syndrome -\n\nExclusion Criteria: secondary transfers from hospital to hospital, traumatic chest pain\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03132935', 'briefTitle': 'Telemedical vs. Conventional Prehospital Care in Acute Coronary Syndromes', 'organization': {'class': 'OTHER', 'fullName': 'RWTH Aachen University'}, 'officialTitle': 'Quality Outcomes in Acute Coronary Syndromes Between Telemedically Supported Paramedics and Conventional On-scene Physician Care', 'orgStudyIdInfo': {'id': 'TEMS-ACS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Telemedicine group', 'description': 'Telemedical care of acute coronary syndromes in the prehospital phase. Paramedics were supported by a physician in a tele consultation centre.', 'interventionNames': ['Procedure: Telemedical support']}, {'label': 'Control group', 'description': 'Conventional on-scene care of acute coronary syndromes by a physician. No telemedicine system was available during this control period.'}], 'interventions': [{'name': 'Telemedical support', 'type': 'PROCEDURE', 'description': 'Telemedical support by a physician in a telemedicine centre', 'armGroupLabels': ['Telemedicine group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52074', 'city': 'Aachen', 'country': 'Germany', 'facility': 'University Hospital Aachen', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RWTH Aachen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}