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

Liverpool Heart and Chest Hospital NHS Foundation Trust

Status: Enrolling

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

Treatments: Device: Radiation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06875583

REDUCE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

RAMPART Arm

Experimental group

Description:

The use of the RAMPART system to reduce operator radiation exposure

Treatment:

Device: Radiation

Standard Arm

No Intervention group

Description:

Standard radiation protection