Simulator Training to Improve Interventional Cardiologist Skills (STARTERS) Trial (NCT06358105) | Clinical Trial Compass
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Simulator Training to Improve Interventional Cardiologist Skills (STARTERS) Trial
Italy400 participantsStarted 2024-11-15
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean total fluoroscopy radiation time (expressed in seconds)