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| Name | Class |
|---|---|
| Rampart Health, L.L.C. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RAMPART Arm | Experimental | The use of the RAMPART system to reduce operator radiation exposure |
|
| Standard Arm | No Intervention | Standard radiation protection |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation | Device | The use of RAMPART radiation protection device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 1st Operator Eye radiation | 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. | 1) Periprocedural 2) Cumulative dose - through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 1st Operator Chest / Groind radiation | 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. | 1) Periprocedural 2) Cumulative dose - through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| John D Hung, MBChB PhD MRCP(UK) | Contact | 0151 600 1657 | 0151 600 1657 | paula.walker@lhch.nhs.uk |
| Debar Rasoul, MBChB BSc MRCP(UK) | Contact | 0151 600 1657 | 0151 600 1657 | paula.walker@lhch.nhs.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liverpool Heart & Chest Hospital | Recruiting | Liverpool | L14 3PE | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39131978 | Result | 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. | |
| 39350833 |
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Direct access will be granted to the Sponsor, host institution and the regulatory authorities to permit trial-related monitoring, audits and inspections in line with participant consent. Furthermore, all data will be shared through publication and via online additional data supplements.
End of trial and publication
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| ID | Term |
|---|---|
| D011832 | Radiation Injuries |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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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.
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| 2nd Operator Radiation - all levels |
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. |
| 1) Periprocedural 2) Cumulative dose - through study completion, an average of 1 year |
| 'Circulating Nurse' Radiation | 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. | 1) Periprocedural 2) Cumulative dose - through study completion, an average of 1 year |
| Result |
| 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. |