ATTENUATE (rAdpad proTecTion drapE iN redUcing rAdiaTion Exposure) Trial

NYU Langone Health

Status: Enrolling

Conditions: Radiation Exposure

Treatments: Device: RADPAD

Study type: Interventional

Funder types: Other

Identifiers

NCT06233578

23-01408

Details and patient eligibility

About

The purpose of this study is to examine the impact of the RADPAD in proximal operators in a contemporary cardiac catheterization laboratory (CCL), during diagnostic, coronary and structural cardiac catheterization procedures, in a large prospective, randomized controlled trial. Up to 1,000 patient-cases and up to 100 proximal operator-subjects expected to be enrolled across 1 site. The proximal operator cohort is expected to include a few interventional cardiologist attending physicians, interventional cardiology fellows, cardiovascular disease fellows and physician assistants performing multiple cases each, which in total would amount to 1,000 cases performed by 100 proximal operators. The primary outcome of interest was relative exposure of the proximal operator between the guideline directed radiation protocols and RADPAD use vs. guideline directed radiation protocols alone.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (Employees):

• Proximal operator of a cardiac catheterization procedure as defined by the individual performing the procedure closest to the source of radiation. This may be either physician assistants of the CCL, fellows of cardiovascular disease, interventional cardiology fellows or attending interventional cardiologists at NYU Langone Hospital - Long Island.
• Age ≥18 years
• Willing and able to consent.

Inclusion Criteria (Patient Cases):

• Cardiac catheterization procedure at NYU Langone Hospital - Long Island.
• Age ≥18 years of the patient undergoing cardiac catheterization.

Exclusion Criteria (Employees):

• Anyone unable or unwilling to give informed consent.
• Anyone pregnant or breastfeeding.
• A proximal operator performing a cardiac catheterization procedure where there are not located on the right-side of the patient and/or behind the radiation shield.
• Any proximal operator who wishes to use the RADPAD regardless of being in the study/is unwilling to be randomized

Exclusion Criteria (Patient Cases):

There are no specific exclusion criteria that pertain exclusively to the cardiac catheterization procedure.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

RADPAD

Experimental group

Description:

Each cardiac catheterization procedure utilizes the standard guideline directed radiation protocol and a single RADPAD will be placed on the patient. All employee participants will wear a radiation detection device at the level of the left side of the chest facing the radiation source over any the protective apron worn by the participant.

Treatment:

Device: RADPAD

No RADPAD

No Intervention group

Description:

Each cardiac catheterization procedure utilizes the standard guideline directed radiation protocol and no RADPAD will be used. All employee participants will wear a radiation detection device at the level of the left side of the chest facing the radiation source over any the protective apron worn by the participant.