Simulation Training For Invasive Cardiovascular Procedures

NCT06224101 | Completed

• 1 other identifier: Heart-SIMS1
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease

Keywords

Education; Invasive coronary angiography; Cardiovascular procedures; 3D-printing; Simulation training

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Conventional training group

NO INTERVENTION

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.

Simulation training group

EXPERIMENTAL

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

Interventions

Simulation-based training BEHAVIORAL

simulation training consists of practicing diagnostic coronary angiography with 3D printed simulator-SimulHeart.

Simulation training group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Pregnant students
• Previous experience in interventional cardiology

Sponsors & Collaborators

• University of Coimbra: lead

Study Sites (1)

Centro Hospitalar e Universitário de Coimbra

Coimbra, 3000-075, Portugal

Location

Related Publications (5)

• 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.

  PMID: 30249587 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

• 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.

  PMID: 28766876 BACKGROUND

• 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.

  PMID: 29748151 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

• Manuel Oliveira Santos, MD

  Coimbra's University - Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 14, 2024
• First Posted: January 25, 2024
• Study Start: December 15, 2023
• Primary Completion: February 1, 2024
• Study Completion: June 9, 2024
• Last Updated: June 11, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)