Coronary Artery Disease
Conditions
Keywords
simulation, training, fellows, coronary artery disease, coronary angiography
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.
Interventions
PROCEDURESimulator-based training
A two-day training program will be performed before starting their cath lab period as interventional cardiology fellows
PROCEDUREStandard training
Standard master-apprentice training interventional cardiology fellows' program during their cath lab period
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 |
| 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 |
| 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 |
Countries
Italy
Contacts
Primary ContactFRANCESCO Burzotta, Prof..
Outcome results
None listed