Clinical trial NCT06358105: Simulator Training to Improve Interventional Cardiologist Skills (STARTERS) Trial
Official title: Simulator Training to Improve Interventional Cardiologist Skills (STARTERS) Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Keywords: simulation
training
fellows
coronary artery disease
coronary angiography
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn if simulator-based training will improve interventional cardiology fellows' skills and will improve patient outcomes.

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.


Eligibility criteria: Inclusion Criteria:

* Specializing doctors who are about to start dedicated training in the interventional cardiology room
* Patients who must undergo coronary angiography examination.

Exclusion Criteria:

Specializing doctors:

* 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

Primary outcomes:
measure: Mean total fluoroscopy radiation time (expressed in seconds)
timeFrame: End of procedure
Secondary outcomes:
measure: Mean arterial cannulation time (expressed in seconds)
timeFrame: End of procedure
measure: Total radiation dose (expressed in cGy*cm2)
timeFrame: End of procedure
measure: Total contrast dose (expressed in ml)
timeFrame: End of procedure
measure: Failure to achieve arterial cannulation (e.g.: rate of failure for each partecipant)
timeFrame: End of procedure
measure: Failure to achieve right coronary cannulation (e.g.: rate of failure for each partecipant)
timeFrame: End of procedure
measure: Failure to achieve left coronary cannulation (e.g.: rate of failure for each partecipant)
timeFrame: End of procedure
measure: Number of catheters used
timeFrame: End of 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)
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Univrsitario Agostino Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Francesco Burzotta, Prof
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.