Clinical trial NCT06875583: The Radiation ProtEction for Dose RedUction in the Cardiac CathEter Lab Study: the REDUCE Trial
Official title: The Radiation ProtEction for Dose RedUction in the Cardiac CathEter Lab Study: the REDUCE Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Radiation Exposure
Radiation Exposure to Operator
Radiation Injuries
Radiation Safety
Keywords: radiation exposure
radiation exposure to operator
radiation injuries
radiation safety
Lead sponsor: Liverpool Heart and Chest Hospital NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Rampart Health, L.L.C.
First posted: 2025-03-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: 1st Operator Eye radiation
timeFrame: 1) Periprocedural 2) Cumulative dose - through study completion, an average of 1 year
Secondary outcomes:
measure: 1st Operator Chest / Groind radiation
timeFrame: 1) Periprocedural 2) Cumulative dose - through study completion, an average of 1 year
measure: 2nd Operator Radiation - all levels
timeFrame: 1) Periprocedural 2) Cumulative dose - through study completion, an average of 1 year
measure: 'Circulating Nurse' Radiation
timeFrame: 1) Periprocedural 2) Cumulative dose - through study completion, an average of 1 year
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.