Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-26 @ 2:13 AM
Study NCT ID:
NCT06358105
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-10
First Post:
2024-04-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Simulator Training to Improve Interventional Cardiologist Skills (STARTERS) Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-11-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-11-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-06', 'studyFirstSubmitDate': '2024-04-02', 'studyFirstSubmitQcDate': '2024-04-06', 'lastUpdatePostDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean total fluoroscopy radiation time (expressed in seconds)', 'timeFrame': 'End of procedure', 'description': 'Difference in Mean total fluoroscopy radiation time, during the periods where the cardiology fellows act as primary operators, between groups'}], 'secondaryOutcomes': [{'measure': 'Mean arterial cannulation time (expressed in seconds)', 'timeFrame': 'End of procedure', 'description': 'Difference in mean coronary cannulation time is considered as the time from sheath insertion to first right and left selective coronary angiography obtained (expressed in minutes)'}, {'measure': 'Total radiation dose (expressed in cGy*cm2)', 'timeFrame': 'End of procedure', 'description': 'Difference in total radiation dose adsorbed by patients as evaluated by dose-area product (DAP) (expressed in Gycm2)'}, {'measure': 'Total contrast dose (expressed in ml)', 'timeFrame': 'End of procedure', 'description': 'Difference in total contrast dose administered to the patients'}, {'measure': 'Failure to achieve arterial cannulation (e.g.: rate of failure for each partecipant)', 'timeFrame': 'End of procedure', 'description': 'Difference in failure to achieve arterial cannulation'}, {'measure': 'Failure to achieve right coronary cannulation (e.g.: rate of failure for each partecipant)', 'timeFrame': 'End of procedure', 'description': 'Difference in failure to achieve right coronary cannulation'}, {'measure': 'Failure to achieve left coronary cannulation (e.g.: rate of failure for each partecipant)', 'timeFrame': 'End of procedure', 'description': 'Difference in failure to achieve left coronary cannulation'}, {'measure': 'Number of catheters used', 'timeFrame': 'End of procedure', 'description': 'Difference in number of catheters used to complete the diagnostic procedure'}, {'measure': 'Any major or minor procedural and clinical complication', 'timeFrame': 'Up to the end of index hospitalization or date of death from any cause (we collect any kind of clinical or procedural complication occuring during the determined period)', 'description': 'Difference in any major or minor complication occurred during the procedure or the index hospitalization'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['simulation', 'training', 'fellows', 'coronary artery disease', 'coronary angiography'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '27397459', 'type': 'BACKGROUND', 'citation': 'Aggarwal S, Choudhury E, Ladha S, Kapoor PM, Kiran U. Simulation in cardiac catheterization laboratory: Need of the hour to improve the clinical skills. Ann Card Anaesth. 2016 Jul-Sep;19(3):521-6. doi: 10.4103/0971-9784.185548.'}, {'pmid': '33419690', 'type': 'BACKGROUND', 'citation': "Pezel T, Coisne A, Bonnet G, Martins RP, Adjedj J, Biere L, Lattuca B, Turpeau S, Popovic B, Ivanes F, Lafitte S, Deharo JC, Bernard A. Simulation-based training in cardiology: State-of-the-art review from the French Commission of Simulation Teaching (Commission d'enseignement par simulation-COMSI) of the French Society of Cardiology. Arch Cardiovasc Dis. 2021 Jan;114(1):73-84. doi: 10.1016/j.acvd.2020.10.004. Epub 2021 Jan 5."}, {'pmid': '21530937', 'type': 'BACKGROUND', 'citation': 'Sciahbasi A, Romagnoli E, Trani C, Burzotta F, Pendenza G, Tommasino A, Leone AM, Niccoli G, Porto I, Penco M, Lioy E. Evaluation of the "learning curve" for left and right radial approach during percutaneous coronary procedures. Am J Cardiol. 2011 Jul 15;108(2):185-8. doi: 10.1016/j.amjcard.2011.03.022. Epub 2011 Apr 29.'}, {'pmid': '29588710', 'type': 'BACKGROUND', 'citation': 'Joshi A, Wragg A. Simulator Training in Interventional Cardiology. Interv Cardiol. 2016 May;11(1):70-73. doi: 10.15420/icr.2016.11.1.70.'}, {'pmid': '30732853', 'type': 'BACKGROUND', 'citation': 'Popovic B, Pinelli S, Albuisson E, Metzdorf PA, Mourer B, Tran N, Camenzind E. The Simulation Training in Coronary Angiography and Its Impact on Real Life Conduct in the Catheterization Laboratory. Am J Cardiol. 2019 Apr 15;123(8):1208-1213. doi: 10.1016/j.amjcard.2019.01.032. Epub 2019 Jan 24.'}, {'pmid': '26671629', 'type': 'BACKGROUND', 'citation': 'Voelker W, Petri N, Tonissen C, Stork S, Birkemeyer R, Kaiser E, Oberhoff M. Does Simulation-Based Training Improve Procedural Skills of Beginners in Interventional Cardiology?--A Stratified Randomized Study. J Interv Cardiol. 2016 Feb;29(1):75-82. doi: 10.1111/joic.12257. Epub 2015 Dec 16.'}]}, 'descriptionModule': {'briefSummary': "The goal of this clinical trial is to learn if simulator-based training will improve interventional cardiology fellows' skills and will improve patient outcomes.\n\nThe main questions it aims to answer are:\n\n* Does this training improve specific operative parameters recorded during initial coronary interventions performed as first operators under senior supervision?\n* Will major and minor procedural complications be reduced after simulator-based training?\n\nInterventional cardiology fellows in their first year of training will be randomized between standard master-apprentice training or simulator-based training before starting their cath lab period.\n\nThey will be supervised during their cath lab period as first operators by senior interventional cardiologists.\n\nDuring their first 50 procedures performed as supervised first operator, specific procedural data will be collected."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Specializing doctors who are about to start dedicated training in the interventional cardiology room\n* Patients who must undergo coronary angiography examination.\n\nExclusion Criteria:\n\nSpecializing doctors:\n\n* No interest in performing interventional cardiology procedures as first supervised operator (classical training)\n* Experience as first supervised operator in interventional cardiology procedures\n* Absence of informed consent\n\nPatients:\n\n* Acute Coronary Syndrome\n* Severe left ventricular dysfunction with ejection fraction less than 30%\n* Severe chronic renal failure (with glomerular filtration rate less than 30 ml/min)\n* Absence of informed consent'}, 'identificationModule': {'nctId': 'NCT06358105', 'acronym': 'STARTERS', 'briefTitle': 'Simulator Training to Improve Interventional Cardiologist Skills (STARTERS) Trial', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Simulator Training to Improve Interventional Cardiologist Skills (STARTERS) Trial', 'orgStudyIdInfo': {'id': 'id. 6457'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Simulator-based training group', 'description': 'Interventional cardiology fellows will undergo a two-day training program on high-fidelity simulators', 'interventionNames': ['Procedure: Simulator-based training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard group', 'description': 'Interventional cardiology fellows will undergo standard training based on master-apprentice model', 'interventionNames': ['Procedure: Standard training']}], 'interventions': [{'name': 'Simulator-based training', 'type': 'PROCEDURE', 'description': 'A two-day training program will be performed before starting their cath lab period as interventional cardiology fellows', 'armGroupLabels': ['Simulator-based training group']}, {'name': 'Standard training', 'type': 'PROCEDURE', 'description': "Standard master-apprentice training interventional cardiology fellows' program during their cath lab period", 'armGroupLabels': ['Standard group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Rome', 'country': 'Italy', 'facility': 'Fondazione Policlinico Univrsitario Agostino Gemelli IRCCS', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'centralContacts': [{'name': 'FRANCESCO Burzotta, Prof..', 'role': 'CONTACT', 'email': 'francesco.burzotta@policlinicogemelli.it', 'phone': '+393494295290'}], 'overallOfficials': [{'name': 'Francesco Burzotta, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondazione Policlinico Universitario A. Gemelli, IRCCS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Burzotta Francesco', 'investigatorAffiliation': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}}}}