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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RADPAD | Experimental | 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. |
|
| No RADPAD | No 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RADPAD | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Operator Exposure (OE)/Dose Area Product (DAP) (uSv[Micro-Sieverts]/mGy[Milligray]*cm2) of the Proximal Operator | 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) |
| OE/DAP (uSv/mGy*cm2) of the Proximal Operator | 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) |
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Inclusion Criteria (Employees):
Inclusion Criteria (Patient Cases):
Exclusion Criteria (Employees):
Exclusion Criteria (Patient Cases):
There are no specific exclusion criteria that pertain exclusively to the cardiac catheterization procedure.
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| Name | Affiliation | Role |
|---|---|---|
| Giorgio A. Medranda, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Hospital - Long Island | New York | New York | 11501 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40274486 | Derived | Medranda GA, Case BC, Bliagos D; ATTENUATE Investigators. The impact of the RADPAD in reducing radiation exposure in a contemporary cardiac Cath Lab: Rationale and design of the ATTENUATE trial. Cardiovasc Revasc Med. 2026 Feb;83:67-69. doi: 10.1016/j.carrev.2025.04.023. Epub 2025 Apr 17. |
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The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: giorgio.medranda@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data will be provided access upon reasonable request. Requests should be directed to giorgio.medranda@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | No RADPAD | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Race and Ethnicity Not Collected
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Operator Exposure (OE)/Dose Area Product (DAP) (uSv[Micro-Sieverts]/mGy[Milligray]*cm2) of the Proximal Operator | This is a continuous variable which will be analyzed statistically using the student's t-test. | Posted | Mean | Standard Deviation | 10,000 x uSv / mGy*cm^2 | From start of each procedure until end of each procedure (up to 1 day) |
|
No AE, SAE, or all-cause mortality data was collected for this study
No AE, SAE, or all-cause mortality data was collected for this study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Giorgio A. Medranda, MD | NYU Langone Health | (516) 877-2626 | giorgio.medranda@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 3, 2024 | Jan 2, 2026 | Prot_SAP_000.pdf |
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|
| BG001 | No RADPAD | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | No RADPAD | 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. |
|
|
| Primary | OE/DAP (uSv/mGy*cm2) of the Proximal Operator | This is a continuous variable which will be analyzed statistically using the student's t-test. | Posted | Mean | Standard Deviation | 10,000 x uSv / mGy*cm^2 | From start of each procedure until end of each procedure (up to 1 day) |
|
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | No RADPAD | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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