Simulator Training to Improve Interventional Cardiologist Skills (STARTERS) Trial

Coronary Artery Disease Clinical Trial

— STARTERS  

Official title:

Simulator Training to Improve Interventional Cardiologist Skills (STARTERS) Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06358105
• Other study ID #: id. 6457
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 15, 2024
• Est. completion date: November 15, 2025

Study information

• Verified date: April 2024
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: FRANCESCO Burzotta, Prof..
• Phone: +393494295290
• Email: francesco.burzotta[@]policlinicogemelli.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: November 15, 2025
• Est. primary completion date: November 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Univrsitario Agostino Gemelli IRCCS	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean total fluoroscopy radiation time (expressed in seconds)	Difference in Mean total fluoroscopy radiation time, during the periods where the cardiology fellows act as primary operators, between groups	End of procedure
Secondary	Mean arterial cannulation time (expressed in seconds)	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)	End of procedure
Secondary	Total radiation dose (expressed in cGy*cm2)	Difference in total radiation dose adsorbed by patients as evaluated by dose-area product (DAP) (expressed in Gycm2)	End of procedure
Secondary	Total contrast dose (expressed in ml)	Difference in total contrast dose administered to the patients	End of procedure
Secondary	Failure to achieve arterial cannulation (e.g.: rate of failure for each partecipant)	Difference in failure to achieve arterial cannulation	End of procedure
Secondary	Failure to achieve right coronary cannulation (e.g.: rate of failure for each partecipant)	Difference in failure to achieve right coronary cannulation	End of procedure
Secondary	Failure to achieve left coronary cannulation (e.g.: rate of failure for each partecipant)	Difference in failure to achieve left coronary cannulation	End of procedure
Secondary	Number of catheters used	Difference in number of catheters used to complete the diagnostic procedure	End of procedure
Secondary	Any major or minor procedural and clinical complication	Difference in any major or minor complication occurred during the procedure or the index hospitalization	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)