Liverpool Heart & Chest Hospital
Liverpool, L14 3PE, United Kingdom
Location status: Recruiting
NCT Number: NCT06875583
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Liverpool, L14 3PE, United Kingdom
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The use of RAMPART radiation protection device
Other names: Use of RAMPART radiation protection device
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Debar Rasoul, MBChB BSc MRCP(UK)
CONTACT
0151 600 1657 ext. 0151 600 1657
John D Hung, MBChB PhD MRCP(UK)
CONTACT
0151 600 1657 ext. 0151 600 1657
Liverpool Heart and Chest Hospital NHS Foundation Trust
Other
Acronym: REDUCE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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