Simulator Training to Improve Interventional Cardiologist Skills (STARTERS) Trial

NCT06358105 | Not Yet Recruiting

• 1 other identifier: id. 6457
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

simulation; training; fellows; coronary artery disease; coronary angiography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Mean arterial cannulation time (expressed in seconds)

  End of procedure

• Total radiation dose (expressed in cGy*cm2)

  End of procedure

• Total contrast dose (expressed in ml)

  End of procedure

• Failure to achieve arterial cannulation (e.g.: rate of failure for each partecipant)

  End of procedure

• Failure to achieve right coronary cannulation (e.g.: rate of failure for each partecipant)

  End of procedure

Study Arms (2)

Simulator-based training group

EXPERIMENTAL

Interventional cardiology fellows will undergo a two-day training program on high-fidelity simulators

Procedure: Simulator-based training

Standard group

ACTIVE COMPARATOR

Interventional cardiology fellows will undergo standard training based on master-apprentice model

Procedure: Standard training

Interventions

Simulator-based training PROCEDURE

A two-day training program will be performed before starting their cath lab period as interventional cardiology fellows

Simulator-based training group

Standard training PROCEDURE

Standard master-apprentice training interventional cardiology fellows' program during their cath lab period

Standard group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Univrsitario Agostino Gemelli IRCCS

Rome, 00168, Italy

Location

Related 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.

  PMID: 27397459 BACKGROUND

• 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: 33419690 BACKGROUND

• 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: 21530937 BACKGROUND

• 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: 29588710 BACKGROUND

• 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: 30732853 BACKGROUND

• 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.

  PMID: 26671629 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Francesco Burzotta, Prof

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

FRANCESCO Burzotta, Prof..

CONTACT

+393494295290; francesco.burzotta@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 10, 2024
• Study Start: November 15, 2024
• Primary Completion: November 15, 2024
• Study Completion: November 15, 2025
• Last Updated: April 10, 2024

Record last verified: 2024-04

Locations

IT (1)