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

Not Applicable

Recruiting

• Conditions: Occupational Radiation Exposure in Interventional Cardiology

• Registration Number: NCT06931171
• Lead Sponsor: National and Kapodistrian University of Athens

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2025-01-30
• Study First Submitted: 2025-02-13
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-09
• Last Update Submitted: 2025-04-09
• Study First Posted: 2025-04-17
• Last Update Posted: 2025-04-17
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Effectiveness of Patient-Applied Pelvic Shielding in Reducing Operator Radiation Exposure During Transradial Coronary Procedures	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).

Trial Locations

Locations (2)

First Department of Cardiology, Hippokration General Hospital of Athens; 🇬🇷 Athens, Attiki, Greece

First Department of Cardiology, National and Kapodistrian University of Athens, Hippokration General Hospital of Athens; 🇬🇷 Athens, Attiki, Greece