Clinical trial NCT06233578: ATTENUATE (rAdpad proTecTion drapE iN redUcing rAdiaTion Exposure) Trial
Official title: ATTENUATE (rAdpad proTecTion drapE iN redUcing rAdiaTion Exposure) Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radiation Exposure
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2024-01-31
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Operator exposure (OE)/dose area product (DAP) (uSv[micro-Sieverts]/mGy[milligray]*cm2) of the proximal operator in which guideline directed radiation protocols and the RADPAD was utilized
timeFrame: From start of each procedure until end of each procedure (up to 1 day)
measure: OE/DAP (uSv/mGy*cm2) of the proximal operator in which only guideline directed radiation protocols were utilized
timeFrame: From start of each procedure until end of each procedure (up to 1 day)
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Hospital - Long Island
state: New York
Study officials:
affiliation: NYU Langone Health
name: Giorgio A. Medranda, MD
role: PRINCIPAL_INVESTIGATOR
References: