Method to reduce radiation exposure for interventional cardiologists
Zero-cost Radiation Protection Method to Reduce Radiation Exposure of Interventional Cardiologists During Transradial Percutaneous Coronary Procedures (FREEPADRAD Trial)
This study tests a new way to protect interventional cardiologists from radiation during heart procedures by using special lead aprons to shield patients, to see if it makes their work safer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National and Kapodistrian University of Athens Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Athens, Attiki and 1 other locations) |
| Trial ID | NCT06931171 on ClinicalTrials.gov |
What this trial studies
This trial evaluates a novel approach to reduce radiation exposure for interventional cardiologists by using medical lead aprons to shield the patient's lower abdomen during transradial coronary procedures. It is a prospective, randomized trial that measures the effectiveness of this additional radiation protection method. The study will assess operator radiation exposure and analyze various clinical and procedural factors that may influence the results. The goal is to enhance safety for healthcare professionals while maintaining the efficacy of interventional cardiology procedures.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older undergoing transradial diagnostic coronary angiography or angioplasty.
Not a fit: Patients with acute STEMI requiring primary PCI or those undergoing structural heart interventions may not benefit from this study.
Why it matters
Potential benefit: If successful, this method could significantly lower radiation exposure for interventional cardiologists, improving their long-term health outcomes.
How similar studies have performed: While there have been various approaches to radiation protection in interventional cardiology, this specific method of patient-applied pelvic shielding is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients undergoing transradial diagnostic coronary angiography or angioplasty. * Adults aged 18 years and older. * Informed consent provided. Exclusion Criteria: * Acute STEMI requiring primary percutaneous coronary intervention (PCI). * Patients undergoing structural heart interventions. * Initially femoral access or crossover to femoral access procedures. * Patients unable to provide informed consent.
Where this trial is running
Athens, Attiki and 1 other locations
- First Department of Cardiology, Hippokration General Hospital of Athens — Athens, Attiki, Greece (Recruiting)
- First Department of Cardiology, National and Kapodistrian University of Athens, Hippokration General Hospital of Athens — Athens, Attiki, Greece (Recruiting)
Study contacts
- Study coordinator: Nikolaos Ktenopoulos, MD, MSc, PhD
- Email: nikosktenop@gmail.com
- Phone: +302132088025
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.