Health TrialsbyHealthPanel

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

ConditionsRadiation ExposureRadiation Exposure to OperatorRadiation InjuriesRadiation Safety
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLiverpool Heart and Chest Hospital NHS Foundation Trust

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Procedures involving patients less than 18 years of age

Patients unable to give valid consent

Pregnancy

Femoral approach procedure

Trial design

Design model

Parallel

Treatments tested in this trial

  • Radiation

    Device

    The use of RAMPART radiation protection device

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: RAMPART ArmExperimental treatment 1 intervention
Group B: Standard ArmNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
1) Periprocedural 2) Cumulative dose - through study completion, an average of 1 year

Secondary outcomes

1

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.

Time frame
1) Periprocedural 2) Cumulative dose - through study completion, an average of 1 year
2

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.

Time frame
1) Periprocedural 2) Cumulative dose - through study completion, an average of 1 year
3

'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.

Time frame
1) Periprocedural 2) Cumulative dose - through study completion, an average of 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Liverpool Heart and Chest Hospital NHS Foundation Trust

Lead sponsor

Rampart Health, L.L.C.

Collaborator

Source ClinicalTrials.gov
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