Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2025-12-26 @ 2:05 AM
Study NCT ID:
NCT04614805
Status:
COMPLETED
Last Update Posted:
2023-01-06
First Post:
2020-10-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Timely Reperfusion in Acute ST-segment Myocardial Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 146}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-01-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-04', 'studyFirstSubmitDate': '2020-10-18', 'studyFirstSubmitQcDate': '2020-10-28', 'lastUpdatePostDateStruct': {'date': '2023-01-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to reperfusion', 'timeFrame': 'This parameter will be recorded within 1 week after patient inclusion', 'description': 'Interval between 1st medical contact and opening of the infarction-related coronary artery.'}], 'secondaryOutcomes': [{'measure': 'Ejection fraction at discharge', 'timeFrame': 'This parameter will be recorded up to 6 months after patient inclusion', 'description': 'Systolic function of the left ventricle'}, {'measure': 'Survival', 'timeFrame': "This parameter will be collected from patient's records during Nov -20 till Aug -21.", 'description': 'Survival after 30 days from incident'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '36203049', 'type': 'DERIVED', 'citation': 'Bartnes K, Albrigtsen H, Iversen JM, Brovold H, Moller NH, Wembstad B, Arstad F, Kristensen AH, Cortis J, Olsen SJ, Nygaard SNS, Kindler SG, Moe O, Hansen C, Mannsverk JT. The Barriers to Rapid Reperfusion in Acute ST-Elevation Myocardial Infarction. Cardiol Ther. 2022 Dec;11(4):559-574. doi: 10.1007/s40119-022-00281-7. Epub 2022 Oct 6.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to monitor outcomes, especially time to reperfusion, in ST-elevation acute myocardial infarction patients.', 'detailedDescription': 'In the regional health trust of North Norway, time to reperfusion in acute ST-elevation myocardial infarction is below the national average and below recommendations. The aim of this study is to monitor outcomes, especially time to reperfusion, in ST-elevation acute myocardial infarction patients. The study period is supposedly lasting for approximately 4 months, the time estimated to observe the clinical course of 100 patients. Before and during the study period, clinical leaders are encouraged to improve guideline adherence and to closely monitor the results of their own and collaborating institutions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients diagnosed with STEMI in our regional health trust during the study period who has an indication for immediate reperfusion therapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient diagnosed with acute myocardial infarction with ST-elevations within our regional health trust during Nov 1st and for approx 4 months, and with an indication for reperfusion therapy (thrombolysis and/pr PCI)\n\nExclusion Criteria:\n\n* Reperfusion therapy not indicated or contraindicated'}, 'identificationModule': {'nctId': 'NCT04614805', 'briefTitle': 'Timely Reperfusion in Acute ST-segment Myocardial Infarction', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital of North Norway'}, 'officialTitle': 'Mobilizing Clinical Leadership to Achieve Timely Reperfusion in Acute ST-segment Elevation Myocardial Infarction', 'orgStudyIdInfo': {'id': 'iTide'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Mobilizing clinical leaders', 'type': 'BEHAVIORAL', 'description': 'Clinical leaders and clinical personnel will regularly receive feedback regarding performance of their own hospital as well as other providers in the regional health trust of North Norway.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '9038', 'city': 'Tromsø', 'state': 'Troms Og Finnmark', 'country': 'Norway', 'facility': 'University Hospital North Norway', 'geoPoint': {'lat': 69.6489, 'lon': 18.95508}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'so far no plans for such sharing.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital of North Norway', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Division of Cardiothoracic and Respiratory Medicine', 'investigatorFullName': 'Kristian Bartnes', 'investigatorAffiliation': 'University Hospital of North Norway'}}}}