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RecruitingNot ApplicableNCT06931171

Zero-cost Radiation Protection Method to Reduce Radiation Exposure of Interventional Cardiologists During Transradial Percutaneous Coronary Procedures (FREEPADRAD Trial)

Sponsor

National and Kapodistrian University of Athens

Enrollment

500 participants

Start Date

Jan 30, 2025

Study Type

INTERVENTIONAL

Conditions

Occupational Radiation Exposure in Interventional Cardiology

Summary

Ionising radiation is a recognised occupational hazard in interventional cardiology. This prospective, randomised trial aims to evaluate the effectiveness of additional radiation protection by existing devices but with a different use, specifically the use of medical lead aprons (designed and used to be worn by the medical and nursing staff for radiation protection) covering the patient's lower abdominal and pelvic area during transradial coronary angiography and angioplasty. The intervention's efficacy will be assessed by measuring the reduction in operator radiation exposure and determining the impact of various clinical and procedural factors.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • Patients undergoing transradial diagnostic coronary angiography or angioplasty.
  • Adults aged 18 years and older.
  • Informed consent provided.

Exclusion Criteria4

  • 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.
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Interventions

RADIATIONPatient-Applied Pelvic Lead Shielding

The intervention involves the application of a triple-layer lead apron to the patient's lower abdominal and pelvic region during transradial coronary procedures. The apron measures 75 cm × 45 cm and is composed of three layers of 0.25 mm Pb-equivalent material. This protective shield is placed on the patient in addition to standard operator radiation protection measures. The primary goal of this intervention is to reduce scatter radiation exposure to the operator, thereby improving occupational safety in the catheterization laboratory. This approach leverages existing radiation protection materials in a novel configuration.

Locations(2)

First Department of Cardiology, Hippokration General Hospital of Athens

Athens, Attica, Greece

First Department of Cardiology, National and Kapodistrian University of Athens, Hippokration General Hospital of Athens

Athens, Attica, Greece

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NCT06931171