ATTENUATE (rAdpad proTecTion drapE iN redUcing rAdiaTion Exposure) Trial

Radiation Exposure Clinical Trial

Official title:

ATTENUATE (rAdpad proTecTion drapE iN redUcing rAdiaTion Exposure) Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06233578
• Other study ID #: 23-01408
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: January 2029

Study information

• Verified date: March 2024
• Source: NYU Langone Health
• Contact: Giorgio A. Medranda, MD
• Phone: (516) 877-2626
• Email: giorgio.medranda[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2029
• Est. primary completion date: January 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Radiation Exposure

Intervention

Device:
• RADPAD
The RADPAD protection drape was designed as a protective scatter-radiation absorbing shield with the goal of reducing scatter radiation. It is a sterile, lead free, light weight, and disposable radiation protection shield that is placed directly over the sterile patient drapes. The RADPAD is comprised of antimony and bismuth providing protection during low-energy fluoroscopy and high-energy cine and Digital subtraction angiography (DSA) settings.

Locations

Country	Name	City	State
United States	NYU Langone Hospital - Long Island	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

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