Simulator Training to Improve Interventional Cardiologist Skills (STARTERS) Trial
NCT ID: NCT06358105
Last Updated: 2024-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
400 participants
INTERVENTIONAL
2024-11-15
2025-11-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The main questions it aims to answer are:
* Does this training improve specific operative parameters recorded during initial coronary interventions performed as first operators under senior supervision?
* Will major and minor procedural complications be reduced after simulator-based training?
Interventional 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.
They will be supervised during their cath lab period as first operators by senior interventional cardiologists.
During their first 50 procedures performed as supervised first operator, specific procedural data will be collected.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of an Optimal Heart Team Protocol on Decision-making Stability
NCT05039567
Evaluation and Treatment of Heart Disease in Patients Not Participating in Research
NCT00001460
The ACTonHEART Study: Design of a Randomized Controlled Clinical Trial of Acceptance and Commitment Therapy for Cardiac Patients
NCT01909102
Short Term Outcomes of Primary Percutaneous Coronary Intervention (PCI) Patients Presented with Acute Heart Failure in Assuit University Heart Hospital
NCT06825780
Implementation of Ischemic Heart Disease Clinical Practice Guidelines
NCT00013104
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Simulator-based training group
Interventional cardiology fellows will undergo a two-day training program on high-fidelity simulators
Simulator-based training
A two-day training program will be performed before starting their cath lab period as interventional cardiology fellows
Standard group
Interventional cardiology fellows will undergo standard training based on master-apprentice model
Standard training
Standard master-apprentice training interventional cardiology fellows' program during their cath lab period
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Simulator-based training
A two-day training program will be performed before starting their cath lab period as interventional cardiology fellows
Standard training
Standard master-apprentice training interventional cardiology fellows' program during their cath lab period
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients who must undergo coronary angiography examination.
Exclusion Criteria
* No interest in performing interventional cardiology procedures as first supervised operator (classical training)
* Experience as first supervised operator in interventional cardiology procedures
* Absence of informed consent
Patients:
* Acute Coronary Syndrome
* Severe left ventricular dysfunction with ejection fraction less than 30%
* Severe chronic renal failure (with glomerular filtration rate less than 30 ml/min)
* Absence of informed consent
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Burzotta Francesco
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Francesco Burzotta, Prof
Role: PRINCIPAL_INVESTIGATOR
Fondazione Policlinico Universitario A. Gemelli, IRCCS
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Fondazione Policlinico Univrsitario Agostino Gemelli IRCCS
Rome, , Italy
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
id. 6457
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.