ATTENUATE (rAdpad proTecTion drapE iN redUcing rAdiaTion Exposure) Trial

Not Applicable

Completed

• Conditions: Radiation Exposure
• Interventions: Device: RADPAD

• Registration Number: NCT06233578
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-10
• Study First Submitted: 2024-01-22
• Study First Submitted QC: 2024-01-22
• Study First Posted: 2024-01-31
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RADPAD	RADPAD	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.

Primary Outcome Measures

Name	Time	Method
OE/DAP (uSv/mGy*cm2) of the proximal operator in which only guideline directed radiation protocols were utilized	From start of each procedure until end of each procedure (up to 1 day)	This is a continuous variable which will be analyzed statistically using the student's t-test.
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	From start of each procedure until end of each procedure (up to 1 day)	This is a continuous variable which will be analyzed statistically using the student's t-test.

Trial Locations

Locations (1)

NYU Langone Hospital - Long Island; 🇺🇸 New York, New York, United States