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

Not Applicable

Not yet recruiting

• Conditions: Radiation Exposure; Radiation Exposure to Operator; Radiation Injuries; Radiation Safety

• Registration Number: NCT06875583
• Lead Sponsor: Liverpool Heart and Chest Hospital NHS Foundation Trust

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.

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 Timeline

• Study First Submitted: 2025-02-17
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-12
• Last Update Submitted: 2025-03-12
• Study First Posted: 2025-03-13
• Last Update Posted: 2025-03-13
• Study Start: 2025-04-01
• Primary Completion: 2026-03-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
1st Operator Eye radiation	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.

Secondary Outcome Measures

Name	Time	Method
1st Operator Chest / Groind radiation	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.
2nd Operator Radiation - all levels	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.
'Circulating Nurse' Radiation	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.