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

November 19, 2025 updated by: John Hung, Liverpool Heart and Chest Hospital NHS Foundation Trust

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Recent decades have seen major increases in x-ray guided procedures in interventional cardiology, radiology and vascular surgery. Exposure to ionising radiation is known to be an inherent risk and remains a serious and unresolved threat to the health of operators and their team. It is associated with an increased incidence of brain and blood cancers, cataracts, and recent mechanistic data indicates significantly increased DNA damage in those without leaded leg protection.

Although existing standard radiation protection measures somewhat reduces exposure, all cardiac catheter lab personnel still receive a certain dose of radiation and continue to accumulate lifetime exposure. Furthermore, leaded personal protective equipment is heavy, leads to orthopaedic complications, and detracts from operator comfort.

Novel radiation protection devices such as RAMPART may significantly reduce radiation doses to cardiac catheter lab personnel, and potentially allow the use of lighter lead, or no lead at all. In this study we aim to investigate if use of RAMPART significantly reduces radiation exposure, when compared with standard radiation protection. Standard coronary intervention procedures will be randomised to RAMPART or standard (radiation protection), and operators and Cath lab team doses will be compared.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • Liverpool, United Kingdom, L14 3PE
        • Recruiting
        • Liverpool Heart & Chest Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RAMPART Arm
The use of the RAMPART system to reduce operator radiation exposure
Device: Radiation
The use of RAMPART radiation protection device
Other Names:
  • Use of RAMPART radiation protection device
No Intervention: Standard Arm
Standard radiation protection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1st Operator Eye radiation
Time Frame: 1) Periprocedural 2) Cumulative dose - through study completion, an average of 1 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
1st Operator Chest / Groind radiation
Time Frame: 1) Periprocedural 2) Cumulative dose - through study completion, an average of 1 year
To assess if RAMPART significantly reduces the radiation dose to first operators during coronary angiography or angioplasty at chest and groin level. Measurement of radiation in µSv.
1) Periprocedural 2) Cumulative dose - through study completion, an average of 1 year
2nd Operator Radiation - all levels
Time Frame: 1) Periprocedural 2) Cumulative dose - through study completion, an average of 1 year
To assess if RAMPART significantly reduces the radiation dose to second operators during coronary angiography or angioplasty at the level of eye, chest and groin. Measurement of radiation in µSv.
1) Periprocedural 2) Cumulative dose - through study completion, an average of 1 year
'Circulating Nurse' Radiation
Time Frame: 1) Periprocedural 2) Cumulative dose - through study completion, an average of 1 year
To assess if RAMPART significantly reduces radiation dose in a more distant position, consistent with that of a 'circulating nurse'. Measurement of radiation in µSv.
1) Periprocedural 2) Cumulative dose - through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Liverpool Heart and Chest Hospital NHS Foundation Trust

Collaborators

Rampart Health, L.L.C.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 29, 2025

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

February 17, 2025

First Submitted That Met QC Criteria

March 12, 2025

First Posted (Actual)

March 13, 2025

Study Record Updates

Last Update Posted (Actual)

November 24, 2025

Last Update Submitted That Met QC Criteria

November 19, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REDUCE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Direct access will be granted to the Sponsor, host institution and the regulatory authorities to permit trial-related monitoring, audits and inspections in line with participant consent. Furthermore, all data will be shared through publication and via online additional data supplements.

IPD Sharing Time Frame

End of trial and publication

IPD Sharing Access Criteria

  1. Published Journal platform
  2. Open Source Framework - https://osf.io/

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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