Clinical trial NCT06931171: Zero-cost Radiation Protection Method to Reduce Radiation Exposure of Interventional Cardiologists During Transradial Percutaneous Coronary Procedures (FREEPADRAD Trial)
Official title: Zero-cost Radiation Protection Method to Reduce Radiation Exposure of Interventional Cardiologists During Transradial Percutaneous Coronary Procedures (FREEPADRAD Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
First posted: 2025-04-17
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: Effectiveness of Patient-Applied Pelvic Shielding in Reducing Operator Radiation Exposure During Transradial Coronary Procedures
timeFrame: During the transradial coronary procedure, measured from the start to the completion of fluoroscopy.
measure: Effectiveness of Patient-Applied Pelvic Shielding in Reducing Operator Radiation Exposure During Transradial Coronary Procedures
timeFrame: During the transradial coronary procedure, measured from the start to the completion of fluoroscopy.
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: First Department of Cardiology, Hippokration General Hospital of Athens
state: Attiki
city: Athens
country: Greece
facility: First Department of Cardiology, National and Kapodistrian University of Athens, Hippokration General Hospital of Athens
state: Attiki
Study officials:
References:
citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.