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Radioprotective Light-weight Caps in the Interventional Cardiology Setting (PROTECT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01620658
Recruitment Status : Completed
First Posted : June 15, 2012
Last Update Posted : September 25, 2014
Sponsor:
Information provided by (Responsible Party):
Raul Herrera, MD, Baptist Health South Florida

Tracking Information
First Submitted Date  ICMJE June 6, 2012
First Posted Date  ICMJE June 15, 2012
Last Update Posted Date September 25, 2014
Study Start Date  ICMJE August 2012
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 9, 2012)
Radiation attenuation in percentage (%) [ Time Frame: 1 day ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 13, 2012)
Radiation attenuation in percentage (%) [ Time Frame: 1 day ]
The null hypothesis is that the XPF 0.5mm lead-equivalent caps attenuation is equal to the XPF 0.25mm 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 0.25mm lead-equivalent and standard cap attenuations.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 9, 2012)
  • Radiation attenuation in absolute terms (uSv) [ Time Frame: 1 day ]
  • Wearing comfort of the collar on a scale from 0-100. [ Time Frame: 1 day ]
    Operators are asked directly after the procedures to rate the wearing comfort
Original Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2012)
  • Radiation attenuation in absolute terms (uSv) [ Time Frame: 1 day ]
  • Wearing comfort of the collar on a scale from 0-100. [ Time Frame: 1 day ]
    Operators are asked directly after each procedure to rate the wearing comfort
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Radioprotective Light-weight Caps in the Interventional Cardiology Setting
Official Title  ICMJE Radioprotective Light-weight Caps in the Interventional Cardiology Setting: a Randomized Controlled Trial
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.
Detailed Description

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.

For more information please contact Dr. Raul Herrera, MD, Director Baptist Cardiac and Vascular Institute Baptist Hospital of Miami.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Condition  ICMJE Occupational Exposure to Radiation
Intervention  ICMJE
  • Device: 0.5mm XPF cap

    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.

  • Device: 0.3mm XPF cap

    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.

  • Device: Standard cap
    Interventionalist wear a standard fabric cap during fluoroscopy guided interventions.
Study Arms  ICMJE
  • Active Comparator: standard cap
    Interventionalist wear a standard fabric cap during fluoroscopy guided interventions.
    Intervention: Device: Standard cap
  • Experimental: 0.3mm XPF cap
    Interventionalist wear a XPF 0.3mm lead equivalent cap during fluoroscopy guided interventions.
    Intervention: Device: 0.3mm XPF cap
  • Experimental: 0.5mm XPF cap
    Interventionalist wear a XPF 0.5mm lead equivalent cap during fluoroscopy guided interventions.
    Intervention: Device: 0.5mm XPF cap
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 13, 2012)
150
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Interventional Cardiologist practicing in Baptist Cardiac & Vascular Institute
  • cardiac procedure requiring C-arm fluoroscopy

Exclusion Criteria:

  • Interventional Neuroradiologists and Interventional Radiologists will not be included in this study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01620658
Other Study ID Numbers  ICMJE PROTECT
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Raul Herrera, MD, Baptist Health South Florida
Study Sponsor  ICMJE Baptist Health South Florida
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Raul Herrera, MD Baptist Hospital of Miami, Miami Cardiac and Vascular Institute
PRS Account Baptist Health South Florida
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP