Simulator Training to Improve Interventional Cardiologist Skills (STARTERS) Trial (STARTERS)

April 6, 2024 updated by: Burzotta Francesco, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Rome, Italy, 00168
        • Fondazione Policlinico Univrsitario Agostino Gemelli IRCCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Simulator-based training group
Interventional cardiology fellows will undergo a two-day training program on high-fidelity simulators
Procedure: Simulator-based training
A two-day training program will be performed before starting their cath lab period as interventional cardiology fellows
Active Comparator: Standard group
Interventional cardiology fellows will undergo standard training based on master-apprentice model
Procedure: Standard training
Standard master-apprentice training interventional cardiology fellows' program during their cath lab period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
End of procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean arterial cannulation time (expressed in seconds)
Time Frame: 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)
End of procedure
Total radiation dose (expressed in cGy*cm2)
Time Frame: End of procedure
Difference in total radiation dose adsorbed by patients as evaluated by dose-area product (DAP) (expressed in Gycm2)
End of procedure
Total contrast dose (expressed in ml)
Time Frame: End of procedure
Difference in total contrast dose administered to the patients
End of procedure
Failure to achieve arterial cannulation (e.g.: rate of failure for each partecipant)
Time Frame: End of procedure
Difference in failure to achieve arterial cannulation
End of procedure
Failure to achieve right coronary cannulation (e.g.: rate of failure for each partecipant)
Time Frame: End of procedure
Difference in failure to achieve right coronary cannulation
End of procedure
Failure to achieve left coronary cannulation (e.g.: rate of failure for each partecipant)
Time Frame: End of procedure
Difference in failure to achieve left coronary cannulation
End of procedure
Number of catheters used
Time Frame: End of procedure
Difference in number of catheters used to complete the diagnostic procedure
End of procedure
Any major or minor procedural and clinical complication
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)
Difference in any major or minor complication occurred during the procedure or the index hospitalization
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

  • Principal Investigator: Francesco Burzotta, Prof, Fondazione Policlinico Universitario A. Gemelli, IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 15, 2024

Primary Completion (Estimated)

November 15, 2024

Study Completion (Estimated)

November 15, 2025

Study Registration Dates

First Submitted

April 2, 2024

First Submitted That Met QC Criteria

April 6, 2024

First Posted (Actual)

April 10, 2024

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 6, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • id. 6457

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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