Simulator Training to Improve Interventional Cardiologist Skills (STARTERS) Trial

N/ANot Yet RecruitingNCT06358105

Fondazione Policlinico Universitario Agostino Gemelli IRCCS400 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

400

Conditions

Coronary Artery Disease

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: End of procedure

Secondary Outcomes

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)

Time frame: 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)

Time frame: End of procedure

Total contrast dose (expressed in ml)

Difference in total contrast dose administered to the patients

Time frame: End of procedure

Failure to achieve arterial cannulation (e.g.: rate of failure for each partecipant)

Difference in failure to achieve arterial cannulation

Time frame: 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

Time frame: 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

Time frame: End of procedure

Number of catheters used

Difference in number of catheters used to complete the diagnostic procedure

Time frame: 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

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)

Simulator Training to Improve Interventional Cardiologist Skills (STARTERS) Trial

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts