Coronary Artery DiseaseHeart-SIMS1NCT06224101
Simulation Training For Invasive Cardiovascular Procedures
A study testing Simulation-based training in people with Coronary Artery Disease, run by University of Coimbra at 1 site in Portugal.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Simulation-based training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 sitePortugal
- Study dates
- 15 Dec 2023to 9 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 6th-year medical students who have read and signed the informed consent
Who cannot join
- Pregnant students
- Previous experience in interventional cardiology
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Centro Hospitalar e Universitário de Coimbra
Coimbra, 3000-075
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Simulation-based training
- Keywords
- Education, Invasive coronary angiography, Cardiovascular procedures, 3D-printing, Simulation training
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulation-based trainingBehavioural
simulation training consists of practicing diagnostic coronary angiography with 3D printed simulator-SimulHeart.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Simulation-based training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start15 Dec 2023
- Primary completion1 Feb 2024
- Study completion9 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Coimbra
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel Oliveira Santos, University of Coimbra
- Investigators
- Manuel Oliveira Santos, MD, Principal investigator, Coimbra's University - Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06224101
- Sponsor's protocol ID
- Heart-SIMS1
- Acronym
- Heart-SIMS1
- Status last verified
- Jun 2024
- First submitted
- 14 Jan 2024
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30249587Popovic 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.
PubMed 30732853Prenner 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.
PubMed 28766876Oliveira-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.
PubMed 29748151Voelker 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.
PubMed 26671629Oliveira-Santos M, Guerreiro C, Lobo B, Marinho AV, Borges-Rosa J, Guardado J, Santos EO, Costa M, Goncalves L, Bogle R, Dudek D, Pires-Morais G, Marques JS, Khokhar AA. Simulation training for invasive cardiovascular procedures: the Heart-SIMS-1 randomized trial. BMC Med Educ. 2026 Mar 14;26(1):650. doi: 10.1186/s12909-026-08831-6.
PubMed 41826935
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart-SIMS1: Simulation Training For Invasive Cardiovascular Procedures
- ClinicalTrials.gov ID
- NCT06224101
- Acronym / sponsor ID
- Heart-SIMS1 / Heart-SIMS1
- Conditions
- Coronary Artery Disease
- Keywords
- Education, Invasive coronary angiography, Cardiovascular procedures, 3D-printing, Simulation training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of CoimbraUniversity, hospital or other
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 9 Jun 2024 (actual)
- First posted
- 25 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Simulation-based trainingThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 6th-year medical students who have read and signed the informed consent
Key exclusion criteria (2 listed)
- Pregnant students
- Previous experience in interventional cardiology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simulation-based trainingsimulation training consists of practicing diagnostic coronary angiography with 3D printed simulator-SimulHeart. | Behavioural | Simulation training group |
Primary outcome
Score of theoretical multiple-choice exam
Time frame: 2 days
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)
Score of pratical evaluation of simulated coronary angiography in a catheterization laboratory
Time frame: 2 days
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)
Final performance score (0-200 points)
Time frame: 2 days
Composite endpoint resulting from the sum of the practical evaluation score and the multiple-choice theoretical test score
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Background: PubMed 30249587Fischer 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.
- Background: PubMed 30732853Popovic 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.
- Background: PubMed 28766876Prenner 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.
- Background: PubMed 29748151Oliveira-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.
- Background: PubMed 26671629Voelker 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.
- Derived from this study: PubMed 41826935Oliveira-Santos M, Guerreiro C, Lobo B, Marinho AV, Borges-Rosa J, Guardado J, Santos EO, Costa M, Goncalves L, Bogle R, Dudek D, Pires-Morais G, Marques JS, Khokhar AA. Simulation training for invasive cardiovascular procedures: the Heart-SIMS-1 randomized trial. BMC Med Educ. 2026 Mar 14;26(1):650. doi: 10.1186/s12909-026-08831-6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manuel Oliveira Santos, MD principal investigator
Coimbra's University - Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulation-based training in people with Coronary Artery Disease, run by University of Coimbra at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score of theoretical multiple-choice exam (time frame: 2 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06224101, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2024.