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NCT Number: NCT06931171

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

First Department of Cardiology, Hippokration General Hospital of Athens, Athens, Attica, Greece

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About this study

Ionizing radiation refers to any type of radiation capable of interacting with matter. It plays a vital role in medical diagnostics and therapeutic applications. Imaging techniques allow for timely and accurate diagnosis, while advanced therapies contribute to longer life expectancy and improved quality of life. However, ionizing radiation carries inherent risks, making its controlled use essential. Radiation exposure is not immediately perceptible but can result in significant damage to the exposed organism. Common effects of high-dose exposure include ocular damage and skin injuries, while radiation is also associated with cellular-level damage, leading to an increased risk of malignancies. Exposure is proportional to time, inversely proportional to the square of the distance from the source, and accumulates over time.

Despite technological advancements and improved X-ray systems, the increasing complexity and frequency of interventional cardiology procedures have led to higher radiation exposure in catheterization laboratories. This poses a major occupational hazard for medical staff, highlighting the need for effective methods to reduce radiation exposure and protect healthcare professionals. Operator radiation exposure varies depending on experience, procedure type, patient characteristics, X-ray system features, and protective measures used. These measures include disposable gloves, shields, lead aprons, and robotic systems.

This prospective, randomised trial evaluates the efficacy of a cost-effective (namely zero-cost) and very easily utilised radiation protection strategy for interventional cardiologists during transradial coronary procedures. By applying a triple-layer lead apron to the patient's pelvic region, the study aims to reduce operator radiation exposure while maintaining standard procedural outcomes. The randomized controlled trial will compare the intervention group utilizing the additional shielding with a control group employing standard radiation protection methods. Key measurements include direct operator radiation exposure and its relation to patient-specific and procedural factors. Findings may establish a practical method for reducing the specific radiation-related occupational hazard related to modern transracial interventional cardiology.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Patient-Applied Pelvic Lead Shielding

Radiation

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.

Primary outcomes

  1. Effectiveness of Patient-Applied Pelvic Shielding in Reducing Operator Radiation Exposure During Transradial Coronary Procedures

    Time frame: During the transradial coronary procedure, measured from the start to the completion of fluoroscopy.

    Primary Outcomes:

    Absolute Operator Radiation Exposure:

    Direct measurement of operator exposure (µSv) using a dosimeter placed outside the lead apron at chest level.

  2. Effectiveness of Patient-Applied Pelvic Shielding in Reducing Operator Radiation Exposure During Transradial Coronary Procedures

    Time frame: During the transradial coronary procedure, measured from the start to the completion of fluoroscopy.

    Primary Outcomes:

    Relative Operator Radiation Exposure:

    Measured as the ratio of operator exposure (µSv) to patient radiation dose area product (cGy·cm²).

Sponsors and collaborators

Lead sponsor

National and Kapodistrian University of Athens

Other

Registry information

Acronym: FREEPADRAD

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 17, 2025
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.