The Radiation ProtEction for Dose RedUction in the Cardiac CathEter Lab Study: The REDUCE Trial

NCT06875583 | Recruiting

• 1 other identifier: REDUCE
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Doctors and nurses who perform heart procedures using X-ray guidance are exposed to radiation, which can be harmful over time. This exposure increases the risk of certain health problems, including cancers, eye damage (cataracts), and DNA damage. Although protective lead clothing is used to reduce exposure, it is heavy, uncomfortable, and can cause muscle and joint problems for those who wear it daily. A new radiation protection device, called RAMPART, may help reduce radiation exposure for heart specialists and their teams. It could also allow them to wear lighter protective gear-or none at all-making their work safer and more comfortable. This study will compare the radiation levels received by doctors and nurses during heart procedures when using RAMPART versus standard protection. By doing so, we hope to find out if this new device can better protect medical teams from radiation, improving both their safety and well-being.

Conditions

Radiation Exposure; Radiation Exposure to Operator; Radiation Injuries; Radiation Safety

Keywords

radiation exposure; radiation exposure to operator; radiation injuries; radiation safety

Outcome Measures

Primary Outcomes (1)

• 1st Operator Eye radiation

  To assess the effect of using a new medical device (RAMPART) in reducing the amount of radiation the first operator is exposed to (at eye level) when performing coronary angiography or angioplasty. Measurement of radiation in µSv.

  1) Periprocedural 2) Cumulative dose - through study completion, an average of 1 year

Secondary Outcomes (3)

• 1st Operator Chest / Groind radiation

  1) Periprocedural 2) Cumulative dose - through study completion, an average of 1 year

• 2nd Operator Radiation - all levels

  1) Periprocedural 2) Cumulative dose - through study completion, an average of 1 year

• 'Circulating Nurse' Radiation

  1) Periprocedural 2) Cumulative dose - through study completion, an average of 1 year

Study Arms (2)

RAMPART Arm

EXPERIMENTAL

The use of the RAMPART system to reduce operator radiation exposure

Device: Radiation

Standard Arm

NO INTERVENTION

Standard radiation protection

Interventions

Radiation DEVICE

The use of RAMPART radiation protection device

Also known as: Use of RAMPART radiation protection device

RAMPART Arm

Eligibility Criteria

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

You may qualify if:

• All procedures involving adult patients (\>18 year of age)
• Male or female patients
• Planned to undergo either an elective or urgent coronary intervention procedure involving ionising radiation in the cardiac catheter lab, via the right and or left radial arteries.

You may not qualify if:

• Procedures involving patients less than 18 years of age
• Patients unable to give valid consent
• Pregnancy
• Femoral approach procedure

Sponsors & Collaborators

• Liverpool Heart and Chest Hospital NHS Foundation Trust: lead
• Rampart Health, L.L.C.: collaborator

Study Sites (1)

Liverpool Heart & Chest Hospital

Liverpool, L14 3PE, United Kingdom

RECRUITING

Related Publications (2)

• Lisko JC, Shekiladze N, Chamoun J, Sheikh N, Rainer K, Wei J, Binongo J, Raj L, Byku I, Rinfret S, Devireddy C, Jaber WA, Greenbaum AB, Babaliaros V, Steuterman S, Sandesara P, Nicholson WJ. Radiation Exposure Using Rampart vs Standard Lead Aprons and Shields During Invasive Cardiovascular Procedures. J Soc Cardiovasc Angiogr Interv. 2023 Oct 19;3(1):101184. doi: 10.1016/j.jscai.2023.101184. eCollection 2024 Jan.

  PMID: 39131978 RESULT

• Noor HA, Althawadi N, Noor Z, AlAnsari N, Chachar TS, Al Raisi S, Yousif N. Radiation Exposure During Invasive Cardiovascular Procedures: Portable Shielding System Versus Standard Lead Aprons. Cureus. 2024 Aug 29;16(8):e68108. doi: 10.7759/cureus.68108. eCollection 2024 Aug.

  PMID: 39350833 RESULT

MeSH Terms

Conditions

Radiation Injuries

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

John D Hung, MBChB PhD MRCP(UK)

CONTACT

0151 600 1657; paula.walker@lhch.nhs.uk

Debar Rasoul, MBChB BSc MRCP(UK)

CONTACT

0151 600 1657; paula.walker@lhch.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Cardiologist, Chief Investigator

Model Details: Multi-centre randomised controlled trial. Coronary catheter laboratory procedures will be randomised 1:1 to RAMPART vs standard radiation protection using a pre-defined randomisation schedule.

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: March 13, 2025
• Study Start: August 29, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: End of trial and publication
• Access Criteria: 1. Published Journal platform 2. Open Source Framework - https://osf.io/

Locations

GB (1)