Simulator Training to Improve Interventional Cardiologist Skills (STARTERS) Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Mean total fluoroscopy radiation time (expressed in seconds)
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Burzotta Francesco
Professor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Eligibility Criteria
Inclusion Criteria
- •Specializing doctors who are about to start dedicated training in the interventional cardiology room
- •Patients who must undergo coronary angiography examination.
Exclusion Criteria
- •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
- •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
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Total radiation dose (expressed in cGy*cm2)(End of procedure)
- Number of catheters used(End of 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))
- Total contrast dose (expressed in ml)(End of procedure)
- Failure to achieve arterial cannulation (e.g.: rate of failure for each partecipant)(End of procedure)
- Mean arterial cannulation time (expressed in seconds)(End of procedure)
- Failure to achieve left coronary cannulation (e.g.: rate of failure for each partecipant)(End of procedure)
- Failure to achieve right coronary cannulation (e.g.: rate of failure for each partecipant)(End of procedure)