Simulation Training For Invasive Cardiovascular Procedures (Heart-SIMS1)

Heart-SIMS1: Simulation Training For Invasive Cardiovascular Procedures

28 sixth-year medical students will attend a theoretical learning session on coronary angiography. After they will be randomized in 2 groups: a conventional training (CT) group (n=14) and a simulation training (ST) group (n=14). CT group will visualize a video-recorded simulation procedure with duration of 20 minutes, while ST group will perform CA simulated training with SimulHeart in groups of two also for 20 minutes. Finally, after the training session, students' knowledge will be assessed through a theoretical multiple-choice exam and a practical evaluation in a catheterization laboratory using SimulHeart.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Behavioral: Simulation-based training

Detailed Description

The simulation protocol starts with a theoretical learning session on invasive coronary angiography (ICA) (1 hour), encompassing the learning objectives (coronary anatomy, procedural indications and safety considerations) for all participants. During the theoretical session, students will be instructed on the most utilized tools for conducting coronary catheterization, along with a step-by-step sequence of the procedure. Medical students will be then randomized to two training methodologies (1:1) using Python programming language, at the same location: a conventional training (CT) group (n=14) and a simulation training (ST) group (n=14). No pre-testing will be performed, because medical students, unlike residents, have limited knowledge on ICA, and randomization will naturally balance both groups. The CT group will visualize a video-recorded simulation procedure with duration of 20 minutes, in which the steps of the ICA are explained. The ST group will perform ICA simulated training with 3D printed simulator SimulHeart in groups of two, with debriefing and feedback. Participants will be taught on how to perform each step of the procedure and guide on safety measures concerning catheter handling, radiation exposure, and contrast administration. The duration of ICA simulated training will be 20 minutes per group. Both types of sessions will have the same instructions and duration (20 minutes). There will be time for questions and answers. After the training session, students' knowledge will be assessed through a theoretical multiple-choice exam, assessing basic coronary artery anatomy knowledge, procedural indications, and safety considerations (scored 0-100 points) and a practical evaluation. The practical evaluation will take place in a catheterization laboratory using SimulHeart simulator at "Unidade de Intervenção Cardiovascular (UNIC), Serviço de Cardiologia do Centro Hospitalar e Universitário de Coimbra (Coimbra, Portugal)". The participants will have to perform pre-specified steps during practical session of diagnostic ICA. The procedure will be video-taped and rated based on performance time, execution of pre-specified steps and monitoring of safety requirements. The student's performance will be evaluated (scored 0-100 points) in real-time and subsequently through review and the analysis of the recorded videos by experts interventionalists, blinded to the randomization and under a checklist of pre-specified safety endpoints and a performance evaluation checklist.

• Study Type: Interventional
• Enrollment (Estimated): 28
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Manuel Oliveira Santos, MD; Phone Number: +351 917174654; Email: manuel_ol_santos@hotmail.com
• Study Contact Backup: Name: Bárbara Lobo; Phone Number: +351 +351937053188; Email: barbara16lobo@gmail.com

Study Locations

• Portugal
  • Coimbra, Portugal, 3000-075
    • Recruiting
    • Centro Hospitalar e Universitário de Coimbra
    • Contact: Manuel Santos, MD; Phone Number: +351 917174654; Email: manuelosantos@chuc.min-saude.pt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Study Population

Twenty-eight sixth-year medical students will be invited to participate in the study and none of them had experience in interventional cardiology.

All participants will have signed the informed consent, voluntarily accepting to take part in the study.

Description

Inclusion Criteria:

• 6th-year medical students who have read and signed the informed consent

Exclusion Criteria:

• Pregnant students
• Previous experience in interventional cardiology

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Conventional training group; The conventional training group will visualize a video-recorded simulation procedure with duration of 20 minutes, in which the steps of the ICA are explained.
Experimental: Simulation training group; The simulation training group will perform coronary angiography simulated training with 3D printed simulator SimulHeart in groups of two, with debriefing and feedback. Participants will be taught on how to perform each step of the procedure and guide on safety measures concerning catheter handling, radiation exposure, and contrast administration. The duration of simulated training will be 20 minutes per group.	Behavioral: Simulation-based training; simulation training consists of practicing diagnostic coronary angiography with 3D printed simulator-SimulHeart.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score of theoretical multiple-choice exam	Students' knowledge of both groups will be assessed through a theoretical multiple-choice exam, assessing basic coronary artery anatomy knowledge, procedural indications, and safety considerations (scored 0-100 points)	2 days
Score of pratical evaluation of simulated coronary angiography in a catheterization laboratory	Students' knowledge of both groups will be assessed through a practical evaluation in a catheterization laboratory using 3D-simulator SimulHeart. The students will have to performe pre-specified steps during pratical session (scored 0-100 points)	2 days
Final performance score (0-200 points)	Composite endpoint resulting from the sum of the practical evaluation score and the multiple-choice theoretical test score	2 days

Collaborators and Investigators

• Sponsor: University of Coimbra
• Investigators: Principal Investigator: Manuel Oliveira Santos, MD, Coimbra's University - Faculty of Medicine

Publications and helpful links

General Publications

• Fischer Q, Sbissa Y, Nhan P, Adjedj J, Picard F, Mignon A, Varenne O. Use of Simulator-Based Teaching to Improve Medical Students' Knowledge and Competencies: Randomized Controlled Trial. J Med Internet Res. 2018 Sep 24;20(9):e261. doi: 10.2196/jmir.9634.
• 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.
• Prenner SB, Wayne DB, Sweis RN, Cohen ER, Feinglass JM, Schimmel DR. Simulation-based education leads to decreased use of fluoroscopy in diagnostic coronary angiography. Catheter Cardiovasc Interv. 2018 May 1;91(6):1054-1059. doi: 10.1002/ccd.27203. Epub 2017 Aug 2.
• Oliveira-Santos M, Oliveira Santos E, Marinho AV, Leite L, Guardado J, Matos V, Pego GM, Marques JS. Patient-specific 3D printing simulation to guide complex coronary intervention. Rev Port Cardiol (Engl Ed). 2018 Jun;37(6):541.e1-541.e4. doi: 10.1016/j.repc.2018.02.007. Epub 2018 May 7. English, Portuguese.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2023
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: January 14, 2024
• First Submitted That Met QC Criteria: January 24, 2024
• First Posted (Actual): January 25, 2024

Study Record Updates

• Last Update Posted (Actual): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 11, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Education; Invasive coronary angiography; 3D-printing; Simulation training; Cardiovascular procedures
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: Heart-SIMS1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No