Trial Radar AI | ||
|---|---|---|
Clinical Trial NCT06875583 (REDUCE) for Radiation Exposure, Radiation Exposure to Operator, Radiation Injuries, Radiation Safety is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
One study matched filter criteria
Card View
The Radiation ProtEction for Dose RedUction in the Cardiac CathEter Lab Study: The REDUCE Trial 100
Clinical Trial NCT06875583 (REDUCE) is an interventional study for Radiation Exposure, Radiation Exposure to Operator, Radiation Injuries, Radiation Safety that is recruiting. It started on 29 August 2025 with plans to enroll 100 participants. Led by Liverpool Heart and Chest Hospital NHS Foundation Trust, it is expected to complete by 1 March 2026. The latest data from ClinicalTrials.gov was last updated on 24 November 2025.
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 radiati...
Show MoreDetailed 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 incr...Show More
Official Title
The Radiation ProtEction for Dose RedUction in the Cardiac CathEter Lab Study: The REDUCE Trial
Conditions
Radiation ExposureRadiation Exposure to OperatorRadiation InjuriesRadiation SafetyPublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- REDUCE
NCT ID Number
Start Date (Actual)
2025-08-29
Last Update Posted
2025-11-24
Completion Date (Estimated)
2026-03-01
Enrollment (Estimated)
100
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
radiation exposure
radiation exposure to operator
radiation injuries
radiation safety
radiation exposure to operator
radiation injuries
radiation safety
Primary Purpose
Supportive Care
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalRAMPART Arm The use of the RAMPART system to reduce operator radiation exposure | Radiation The use of RAMPART radiation protection device |
No InterventionStandard Arm Standard radiation protection | N/A |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | 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 |
| Outcome Measure | 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 |
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 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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.
- Procedures involving patients less than 18 years of age
- Patients unable to give valid consent
- Pregnancy
- Femoral approach procedure
Liverpool Heart and Chest Hospital NHS Foundation TrustRampart Health, L.L.C.Study Responsible Party
John Hung, Principal Investigator, Consultant Cardiologist, Chief Investigator, Liverpool Heart and Chest Hospital NHS Foundation Trust
Study Central Contact
Contact: John D Hung, MBChB PhD MRCP(UK), 0151 600 1657, [email protected]
Contact: Debar Rasoul, MBChB BSc MRCP(UK), 0151 600 1657, [email protected]
1 Study Locations in 1 Countries
Liverpool Heart & Chest Hospital, Liverpool, L14 3PE, United Kingdom
John D Hung, MBChB PhD MRCP(UK), Contact, 0151 600 1657, [email protected]
Recruiting