Simulator Training to Improve Interventional Cardiologist Skills (STARTERS) Trial

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Not yet enrolling

Conditions: Coronary Artery Disease

Treatments: Procedure: Standard training; Procedure: Simulator-based training

Study type: Interventional

Funder types: Other

Identifiers

NCT06358105

id. 6457

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Simulator-based training group

Experimental group

Description:

Interventional cardiology fellows will undergo a two-day training program on high-fidelity simulators

Treatment:

Procedure: Simulator-based training

Standard group

Active Comparator group

Description:

Interventional cardiology fellows will undergo standard training based on master-apprentice model

Treatment:

Procedure: Standard training