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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-29

Study Completion Date

2026-03-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Radiation Exposure Radiation Exposure to Operator Radiation Injuries Radiation Safety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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RAMPART Arm

The use of the RAMPART system to reduce operator radiation exposure

Group Type EXPERIMENTAL

Radiation

Intervention Type DEVICE

The use of RAMPART radiation protection device

Standard Arm

Standard radiation protection

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Radiation

The use of RAMPART radiation protection device

Intervention Type DEVICE

Other Intervention Names

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Use of RAMPART radiation protection device

Eligibility Criteria

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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.