Radioprotective Light-weight Caps in the Interventional Cardiology Setting
PROTECT
1 other identifier
interventional
197
1 country
1
Brief Summary
The primary objective of the present trial is to compare the radiation attenuation provided by XPF caps (0.5mm lead-equivalent and 0.3mm lead-equivalent) to the standard protection (fabric cap, basically no protection) as measured in % radiation attenuation) during 150 days of fluoroscopy guided cardiology interventions. The second objective is to compare the operator comfort (rated on a visual analog scale) of wearing the XPF protection caps compared to the standard fabric caps.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 6, 2012
CompletedFirst Posted
Study publicly available on registry
June 15, 2012
CompletedStudy Start
First participant enrolled
August 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedResults Posted
Study results publicly available
October 21, 2021
CompletedMarch 7, 2022
September 1, 2021
1.6 years
June 6, 2012
July 20, 2015
February 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Radiation Attenuation in Percentage (%)
The null hypothesis is that the XPF 0.5mm lead-equivalent caps attenuation is equal to the XPF 0.3mm lead-equivalent and standard cap attenuations. The alternative hypothesis is that the XPF 0.5mm lead-equivalent cap attenuation is superior or inferior to the XPF 0.3mm lead-equivalent and standard cap attenuations. The groups will be compared separately and a pooled analysis, comparing XPF 0.5mm and 0.3mm combined vs. standard is also planned.The radiation protection (radiation dose reduction) expressed as a percentage was calculated by subtracting radiation measured underneath the cap from radiation measured outside the cap and then dividing this difference by the product of radiation measured outside the cap multiplied by 100.
1 day
Absolute Radiation Exposure Outside of Cap
The cumulative radiation doses were defined as the summation of all correspondent equivalent doses measured.
1 day
Secondary Outcomes (2)
Operator Comfort Assessment
1 day per participant, a total of 197 operator days
Operator Comfort Assessment Based on Weight
1 day per participant, a total of 197 operator days
Study Arms (3)
standard cap
ACTIVE COMPARATORInterventionalist wear a standard fabric cap during fluoroscopy guided interventions.
0.3mm XPF cap
EXPERIMENTALInterventionalist wear a XPF 0.3mm lead equivalent cap during fluoroscopy guided interventions.
0.5mm XPF cap
EXPERIMENTALInterventionalist wear a XPF 0.5mm lead equivalent cap during fluoroscopy guided interventions.
Interventions
Interventionalist wear a XPF 0.5mm lead equivalent cap during fluoroscopy guided interventions. XPF is a trademark of BloXR (Salt lake City, UT) for a new bi-layer (Barium/Bismuth) radiation attenuation material.
Interventionalist wear a XPF 0.3mm lead equivalent cap during fluoroscopy guided interventions. XPF is a trademark of BloXR (Salt lake City, UT) for a new bi-layer (Barium/Bismuth) radiation attenuation material.
Interventionalist wear a standard fabric cap during fluoroscopy guided interventions.
Eligibility Criteria
You may qualify if:
- Interventional Cardiologist practicing in Baptist Cardiac \& Vascular Institute
- cardiac procedure requiring C-arm fluoroscopy
You may not qualify if:
- Interventional Neuroradiologists and Interventional Radiologists will not be included in this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Baptist Hospital of Miami, Miami Cardiac and Vascular Institute
Miami, Florida, 33176, United States
Related Publications (1)
Uthoff H, Quesada R, Roberts JS, Baumann F, Schernthaner M, Zaremski L, Hajirawala L, Katzen BT, Staub D, Kreusch AS. Radioprotective lightweight caps in the interventional cardiology setting: a randomised controlled trial (PROTECT). EuroIntervention. 2015 May;11(1):53-9. doi: 10.4244/EIJV11I1A9.
PMID: 25982649RESULT
Results Point of Contact
- Title
- Raul Herrera, MD. Director Miami Cardiac and Vascular Institute, Research and Outcomes
- Organization
- Baptist Health South Florida
Study Officials
- PRINCIPAL INVESTIGATOR
Raul Herrera, MD
Baptist Hospital of Miami, Miami Cardiac and Vascular Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Division of Clinical Research & Outcomes
Study Record Dates
First Submitted
June 6, 2012
First Posted
June 15, 2012
Study Start
August 1, 2012
Primary Completion
March 1, 2014
Study Completion
April 1, 2014
Last Updated
March 7, 2022
Results First Posted
October 21, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share