Simulator Training to Improve Interventional Cardiologist Skills (STARTERS) Trial
- Conditions
- Coronary Artery Disease
- Registration Number
- NCT06358105
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 400
- Specializing doctors who are about to start dedicated training in the interventional cardiology room
- Patients who must undergo coronary angiography examination.
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Mean total fluoroscopy radiation time (expressed in seconds) End of procedure Difference in Mean total fluoroscopy radiation time, during the periods where the cardiology fellows act as primary operators, between groups
- Secondary Outcome Measures
Name Time Method Total radiation dose (expressed in cGy*cm2) End of procedure Difference in total radiation dose adsorbed by patients as evaluated by dose-area product (DAP) (expressed in Gycm2)
Number of catheters used End of procedure Difference in number of catheters used to complete the diagnostic procedure
Any major or minor procedural and clinical complication 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) Difference in any major or minor complication occurred during the procedure or the index hospitalization
Total contrast dose (expressed in ml) End of procedure Difference in total contrast dose administered to the patients
Failure to achieve arterial cannulation (e.g.: rate of failure for each partecipant) End of procedure Difference in failure to achieve arterial cannulation
Mean arterial cannulation time (expressed in seconds) End of procedure 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)
Failure to achieve left coronary cannulation (e.g.: rate of failure for each partecipant) End of procedure Difference in failure to achieve left coronary cannulation
Failure to achieve right coronary cannulation (e.g.: rate of failure for each partecipant) End of procedure Difference in failure to achieve right coronary cannulation
Trial Locations
- Locations (1)
Fondazione Policlinico Univrsitario Agostino Gemelli IRCCS
🇮🇹Rome, Italy
Fondazione Policlinico Univrsitario Agostino Gemelli IRCCS🇮🇹Rome, Italy