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

NCT06931171 | Active Not Recruiting DMC

• 1 other identifier: FREEPADRAD
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 2

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.

Conditions

Occupational Radiation Exposure in Interventional Cardiology

Keywords

Occupational Radiation Exposure; Interventional Cardiology; Radiation Protection; Transradial Access; Radiation Safety; Operator Radiation Dose; Radiation Hazard Reduction

Outcome Measures

Primary Outcomes (2)

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

  Primary Outcomes: Absolute Operator Radiation Exposure: Direct measurement of operator exposure (µSv) using a dosimeter placed outside the lead apron at chest level.

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

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

  Primary Outcomes: Relative Operator Radiation Exposure: Measured as the ratio of operator exposure (µSv) to patient radiation dose area product (cGy·cm²).

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

Study Arms (2)

Use of conventional radiation protection measures.

NO INTERVENTION

This group will undergo transradial coronary procedures using only conventional radiation protection measures. These include standard operator lead aprons, fixed protective drapes, and other standard shielding equipment typically employed in the catheterization laboratory. No additional radiation protection devices or techniques will be applied to the patient. This arm serves as the baseline for comparison with the intervention group.

Additional patient-applied pelvic lead shielding

EXPERIMENTAL

This group will undergo transradial coronary procedures with the addition of a patient-applied pelvic lead shield. Alongside the conventional radiation protection measures used in the control group, a triple-layer lead apron will be placed over the patient's lower abdominal and pelvic region. This shield, composed of three 0.25 mm Pb-equivalent layers, is designed to reduce scatter radiation exposure to the operator. The intervention aims to assess the effectiveness of this additional protective measure in reducing operator radiation dose.

Radiation: Patient-Applied Pelvic Lead Shielding

Interventions

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.

Additional patient-applied pelvic lead shielding

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead

Study Sites (2)

First Department of Cardiology, Hippokration General Hospital of Athens

Athens, Attica, 11527, Greece

Location

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

Athens, Attica, 11527, Greece

Location

Related Publications (6)

• Shah RM, Patel D, Abbate A, Cowley MJ, Jovin IS. Comparison of transradial coronary procedures via right radial versus left radial artery approach: A meta-analysis. Catheter Cardiovasc Interv. 2016 Dec;88(7):1027-1033. doi: 10.1002/ccd.26519. Epub 2016 Apr 1.

  PMID: 27037544 RESULT

• Vijayalakshmi K, Kelly D, Chapple CL, Williams D, Wright R, Stewart MJ, Hall JA, Sutton A, Davies A, Haywood J, de Belder MA. Cardiac catheterisation: radiation doses and lifetime risk of malignancy. Heart. 2007 Mar;93(3):370-1. doi: 10.1136/hrt.2006.098731. No abstract available.

  PMID: 17322516 RESULT

• Gutierrez-Barrios A, Camacho-Galan H, Medina-Camacho F, Canadas-Pruano D, Jimenez-Moreno A, Calle-Perez G, Vazquez-Garcia R. Effective Reduction of Radiation Exposure during Cardiac Catheterization. Tex Heart Inst J. 2019 Jun 1;46(3):167-171. doi: 10.14503/THIJ-17-6548. eCollection 2019 Jun.

  PMID: 31708696 RESULT

• Sciahbasi A, Piccaluga E, Sarandrea A, Nucci G, Caretto N, Rigattieri S, Fedele S, Romano S, Penco M. Operator Pelvic Radiation Exposure During Percutaneous Coronary Procedures. J Invasive Cardiol. 2018 Feb;30(2):71-74. Epub 2017 Dec 15.

  PMID: 29245152 RESULT

• Anadol R, Brandt M, Merz N, Knorr M, Ahoopai M, Geyer M, Krompiec D, Wenzel P, Munzel T, Gori T. Effectiveness of additional X-ray protection devices in reducing scattered radiation in radial intervention: the ESPRESSO randomised trial. EuroIntervention. 2020 Oct 23;16(8):663-671. doi: 10.4244/EIJ-D-19-00945.

  PMID: 32338611 RESULT

• Venneri L, Rossi F, Botto N, Andreassi MG, Salcone N, Emad A, Lazzeri M, Gori C, Vano E, Picano E. Cancer risk from professional exposure in staff working in cardiac catheterization laboratory: insights from the National Research Council's Biological Effects of Ionizing Radiation VII Report. Am Heart J. 2009 Jan;157(1):118-24. doi: 10.1016/j.ahj.2008.08.009.

  PMID: 19081407 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cardiology, Principal Investigator, Interventional Cardiologist

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: April 17, 2025
• Study Start: January 30, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GR (2)