Coronary Artery DiseaseSTARTERSNCT06358105
Simulator Training to Improve Interventional Cardiologist Skills (STARTERS) Trial
A study testing Simulator-based training and Standard training in people with Coronary Artery Disease, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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… 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?
- Simulator-based training and Standard training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteItaly
- Study dates
- 15 Nov 2024to 15 Nov 2025
- 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
- Specializing doctors who are about to start dedicated training in the interventional cardiology room
- Patients who must undergo coronary angiography examination.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Policlinico Univrsitario Agostino Gemelli IRCCS
Rome, 00168
About this study
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:
Read more
- 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
- Being tested
- Simulator-based training, Standard training
- Keywords
- simulation, training, fellows, coronary artery disease, coronary angiography
- 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.
Simulator-based trainingProcedure or surgery
A two-day training program will be performed before starting their cath lab period as interventional cardiology fellows
Standard trainingProcedure or surgery
Standard master-apprentice training interventional cardiology fellows' program during their cath lab period
| Study group | Role | What they receive |
|---|---|---|
| Simulator-based training group | Experimental | Interventional cardiology fellows will undergo a two-day training program on high-fidelity simulators Receives: Procedure: Simulator-based training |
| Standard group | Active comparator | Interventional cardiology fellows will undergo standard training based on master-apprentice model Receives: Procedure: Standard training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: End of procedure
Secondary outcomes (8)
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)
Measured: End of procedure
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)
Measured: End of procedure
Total contrast dose (expressed in ml)
Difference in total contrast dose administered to the patients
Measured: End of procedure
Failure to achieve arterial cannulation (e.g.: rate of failure for each partecipant)
Difference in failure to achieve arterial cannulation
Measured: End of procedure
Failure to achieve right coronary cannulation (e.g.: rate of failure for each partecipant)
Difference in failure to achieve right coronary cannulation
Measured: End of procedure
Failure to achieve left coronary cannulation (e.g.: rate of failure for each partecipant)
Difference in failure to achieve left coronary cannulation
Measured: End of procedure
Number of catheters used
Difference in number of catheters used to complete the diagnostic procedure
Measured: End of procedure
Any major or minor procedural and clinical complication
Difference in any major or minor complication occurred during the procedure or the index hospitalization
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start15 Nov 2024 (estimated)
- Primary completion15 Nov 2024 (estimated)
- Study completion15 Nov 2025 (estimated)
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.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burzotta Francesco, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Francesco Burzotta, Prof, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06358105
- Sponsor's protocol ID
- id. 6457
- Acronym
- STARTERS
- Status last verified
- Apr 2024
- First submitted
- 2 Apr 2024
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27397459Pezel 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.
PubMed 33419690Sciahbasi 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.
PubMed 21530937Joshi A, Wragg A. Simulator Training in Interventional Cardiology. Interv Cardiol. 2016 May;11(1):70-73. doi: 10.15420/icr.2016.11.1.70.
PubMed 29588710Popovic 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 30732853Voelker 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 26671629
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simulator Training to Improve Interventional Cardiologist Skills (STARTERS) Trial
- ClinicalTrials.gov ID
- NCT06358105
- Acronym / sponsor ID
- STARTERS / id. 6457
- Conditions
- Coronary Artery Disease
- Keywords
- simulation, training, fellows, coronary artery disease, coronary angiography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 15 Nov 2024 (estimated)
- Primary completion
- 15 Nov 2024 (estimated)
- Study completion
- 15 Nov 2025 (estimated)
- First posted
- 10 Apr 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simulator-based training group | Experimental | Procedure: Simulator-based trainingInterventional cardiology fellows will undergo a two-day training program on high-fidelity simulators |
| Standard group | Active comparator | Procedure: Standard trainingInterventional cardiology fellows will undergo standard training based on master-apprentice model |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Specializing doctors who are about to start dedicated training in the interventional cardiology room
- Patients who must undergo coronary angiography examination.
Key exclusion criteria (9 listed)
- 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
- Acute Coronary Syndrome
- Severe left ventricular dysfunction with ejection fraction less than 30%
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 |
|---|---|---|
| Simulator-based trainingA two-day training program will be performed before starting their cath lab period as interventional cardiology fellows | Procedure or surgery | Simulator-based training group |
| Standard trainingStandard master-apprentice training interventional cardiology fellows' program during their cath lab period | Procedure or surgery | Standard group |
Primary outcome
Mean total fluoroscopy radiation time (expressed in seconds)
Time frame: End of procedure
Difference in Mean total fluoroscopy radiation time, during the periods where the cardiology fellows act as primary operators, between groups
8 secondary outcomes
Mean arterial cannulation time (expressed in seconds)
Time frame: End of procedure
Total radiation dose (expressed in cGy*cm2)
Time frame: End of procedure
Total contrast dose (expressed in ml)
Time frame: End of procedure
Failure to achieve arterial cannulation (e.g.: rate of failure for each partecipant)
Time frame: End of procedure
Failure to achieve right coronary cannulation (e.g.: rate of failure for each partecipant)
Time frame: End of procedure
Failure to achieve left coronary cannulation (e.g.: rate of failure for each partecipant)
Time frame: End of procedure
Number of catheters used
Time frame: End of procedure
Any major or minor procedural and clinical complication
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Background: PubMed 27397459Aggarwal 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.
- Background: PubMed 33419690Pezel 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.
- Background: PubMed 21530937Sciahbasi 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.
- Background: PubMed 29588710Joshi A, Wragg A. Simulator Training in Interventional Cardiology. Interv Cardiol. 2016 May;11(1):70-73. doi: 10.15420/icr.2016.11.1.70.
- 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 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.
Related trials for Coronary Artery Disease
Not yet recruitingObservational study
Assessment of Transnational Performance of the Universal Cardiac Surgical Risk Score Across International Sites
Heart Valve Diseases, Cardiac Surgical Procedures
Not yet recruiting
Sirolimus-Coated Versus Paclitaxel-Coated Balloon for Recurrent Coronary In-Stent Restenosis After Prior Paclitaxel-Coated Balloon Treatment (SPRIT)
Coronary In-stent Restenosis, Coronary Artery Disease
RecruitingObservational study
Norepinephrine in the Management of General Anesthesia-Induced Arterial Hypotension in Chronic Heart Failure Patients
Hypotension
Active, not recruitingObservational study
The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
RecruitingObservational study
Cardiovascular Risk Assessment For Kidney Transplantation - Utility of Computed Tomography Coronary Angiography in the Assessment of Patients Awaiting Kidney Transplantation
Cardiovascular Diseases, Kidney Transplant; Complications
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.
Francesco Burzotta, Prof principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulator-based training and Standard training in people with Coronary Artery Disease, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 2 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 10 Apr 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact FRANCESCO Burzotta, Prof.. (+393494295290, francesco.burzotta@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean total fluoroscopy radiation time (expressed in seconds) (time frame: End of procedure). 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 NCT06358105, 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 10 Apr 2024.