RADPAD for Reducing Radiation Exposure

Overseen By Giorgio A. Medranda, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Pregnant, Breastfeeding, Unwilling to consent, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 1 day per procedure

1000 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment RADPAD for reducing radiation exposure?

Research shows that RADPAD, a lead-free drape, significantly reduces radiation exposure for medical staff during procedures like coronary angiography and percutaneous coronary intervention. Studies found that using RADPAD resulted in a lower radiation dose to operators compared to not using it, demonstrating its effectiveness in minimizing radiation exposure. ^{1 2 3 4 5}

How does the RADPAD treatment differ from other treatments for reducing radiation exposure?

RADPAD is unique because it is a lead-free, sterile drape that uses bismuth and barium to reduce scattered radiation during fluoroscopic procedures, unlike traditional lead-based shields. This makes it lighter and potentially more comfortable for use in various medical settings. ^{1 2 3 5 6}

What is the purpose of this trial?

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.

Research Team

Giorgio A. Medranda, MD

Principal Investigator

NYU Langone Health

Eligibility Criteria

The ATTENUATE trial is for healthcare professionals like physician assistants, cardiology fellows, and interventional cardiologists who perform cardiac catheterization procedures at NYU Langone Hospital - Long Island. Participants must be over 18 years old and able to give consent.

Inclusion Criteria

I am willing and able to give my consent.

I am scheduled for a heart catheterization procedure at NYU Langone Hospital - Long Island.

I am the main operator in cardiac catheterization procedures at NYU Langone Hospital - Long Island.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Cardiac catheterization procedures are performed with and without the RADPAD to assess radiation exposure

Up to 1 day per procedure

Multiple procedures per operator

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• RADPAD

Trial Overview This study tests the RADPAD's effectiveness in reducing radiation exposure to medical staff during heart-related catheterization procedures. It involves comparing standard radiation safety measures with and without the use of RADPAD in a large-scale, randomized controlled trial.

Participant Groups

Group I: RADPAD Experimental Treatment 1 Intervention

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.

Group II: No RADPAD Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Findings from Research

In a study involving 137 patients undergoing coronary angiography and percutaneous coronary intervention, the use of RADPAD significantly reduced radiation exposure for the primary operator (PO) compared to procedures without it, with reductions in dose relative to various measures (CAST, DAP, and AK).

The findings also indicated that secondary operators (SO) experienced similar reductions in radiation exposure when RADPAD was used, highlighting its effectiveness in enhancing safety during fluoroscopic procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimizing scattered radiation dose in cardiac catheterization laboratory during interventional procedures using lead free drape - MILD study. Bhat, KG., Guleria, VS., Singla, M., et al.[2022]

In a randomized study of 60 patients undergoing coronary angiography, the use of the Radpad radiation shield significantly reduced the operator's radiation exposure by 23%, despite similar procedure times and total examination doses.

The Radpad shield provided consistent reductions in radiation exposure across various body locations, ranging from 13% to 34%, highlighting its effectiveness in protecting healthcare workers during interventional procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction of scatter radiation during transradial percutaneous coronary angiography: a randomized trial using a lead-free radiation shield. Politi, L., Biondi-Zoccai, G., Nocetti, L., et al.[2022]

The use of the RadPad™ radiation-attenuating drape during cardiac resynchronization therapy (CRT) procedures significantly reduces radiation exposure to physicians, with a 65% reduction for hands and body and a 40% reduction for eyes.

No technical issues or acute skin reactions were reported with the RadPad™, and its application took less than 30 seconds, suggesting it is a safe and practical option for enhancing safety during CRT procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The benefits of using a bismuth-containing, radiation-absorbing drape in cardiac resynchronization implant procedures. Jones, MA., Cocker, M., Khiani, R., et al.[2019]

The use of RADPAD surgical drapes during percutaneous coronary interventions (PCI) significantly reduced radiation exposure to the primary operator, with a mean dose of 3.679 mrem compared to 8.12 mrem in the control group, indicating a strong efficacy in protecting medical staff.

This study, involving 53 patients, demonstrates that RADPAD not only lowers radiation doses for operators but also supports the safety of using radiation-absorbing equipment in clinical settings, making it a recommended practice during coronary angioplasty.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction in Primary Operator Radiation Dose Exposure During Coronary Angioplasty Using Radiation Absorbing Drape. Sharma, AB., Agrawal, R.[2023]

The use of RADPAD during complex percutaneous coronary interventions (PCI) significantly reduced radiation exposure to operators by 39%, despite similar fluoroscopy times and total radiation doses compared to procedures without RADPAD.

Among different angiographic projections, the Left Anterior Oblique (LAO) views emitted significantly higher radiation doses, highlighting the need for enhanced radiation protection in these orientations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of RADPAD protection drape in reducing radiation exposure in the catheterization laboratory-First Indian study. Shah, P., Khanna, R., Kapoor, A., et al.[2020]

The RADPAD surgical drape significantly reduces radiation exposure to primary operators during routine diagnostic coronary angiography, with a 59% reduction in total radiation exposure and a 47% reduction in the radiation exposure rate.

In a study involving 60 patients, the primary operator's radiation dose was significantly lower when using the RADPAD (8.0 µSv) compared to the control group (19.6 µSv), indicating its efficacy in protecting healthcare staff from ionizing radiation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of RADPAD protective drape during coronary angiography. Kherad, B., Jerichow, T., Blaschke, F., et al.[2019]

References

1. India pubmed.ncbi.nlm.nih.gov

Minimizing scattered radiation dose in cardiac catheterization laboratory during interventional procedures using lead free drape - MILD study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Reduction of scatter radiation during transradial percutaneous coronary angiography: a randomized trial using a lead-free radiation shield. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

The benefits of using a bismuth-containing, radiation-absorbing drape in cardiac resynchronization implant procedures. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Reduction in Primary Operator Radiation Dose Exposure During Coronary Angioplasty Using Radiation Absorbing Drape. [2023]

5. India pubmed.ncbi.nlm.nih.gov

Efficacy of RADPAD protection drape in reducing radiation exposure in the catheterization laboratory-First Indian study. [2020]

6. Germany pubmed.ncbi.nlm.nih.gov

Efficacy of RADPAD protective drape during coronary angiography. [2019]