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Trial record 1 of 1 for:    NCT01910272
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Brain Radiation Exposure and Attenuation During Invasive Cardiology Procedures (BRAIN)

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ClinicalTrials.gov Identifier: NCT01910272
Recruitment Status : Completed
First Posted : July 29, 2013
Last Update Posted : July 29, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:
Invasive cardiac procedures involve procedural guidance with x-rays in the form of fluoroscopy. X-ray exposure poses a potential risk of acute and long-term complications to staff involved in these procedures. Lead shields are placed between the operators (on their left side) and the x-ray source to limit exposure. However as the operator requires direct access to the patient and x-ray scatter occurs, full protection is not possible. Lead gowns, thyroid collars, and leaded glasses are typically worn to protect the body, thyroid, and eyes respectively, but their thickness is limited by their relatively heavy weight. Nevertheless this leaves the brain exposed. Further, interest in the risk of brain cancer in invasive cardiologists has re-emerged after a recent report of left-sided brain cancer in primary operators of interventional cardiology procedures. Lead caps have been tested in the past but the relatively heavyweight of lead has limited wide-spread implementation. The cap typically worn during invasive procedures is lightweight, has no significant x-ray absorption properties, and is worn to help maintain a sterile environment. A novel, lead-free cap, composed mainly of barium sulfate and bismuth oxide, has been developed that has been shown to absorb x-rays while being significantly lighter than lead. The investigators propose using multiple x-ray detectors to test exposure differences between the primary and secondary operators, the left side and right side of the head, and absorption via a lead-free cap.

Condition or disease Intervention/treatment
Radiation Effects Device: All subjects are wearing the non-lead attenuation cap (BLOXR)

Detailed Description:

This is a prospective study evaluating radiation exposure to operators of invasive cardiovascular procedures at the UCSD Medical Center in La Jolla. Primary and secondary operators of cardiac catheterization procedures using fluoroscopy guidance, including cardiac catheterization, coronary angiography, and interventional procedures will wear multiple dosimeters to evaluate levels of radiation exposure. The primary and secondary operators will wear six dosimeters on their heads; three outside the non-lead attenuating cap and three underneath the cap. Above and beneath the cap, the dosimeters will be on the left side, in the center, and on the right side of the head. The dosimeters will be worn for a target of at least 50 procedures for each operator. The primary operators will be closest to the procedural site and the fluoroscopy unit for the majority of the procedure, while the secondary operators will be to the right side of the primary operators during the procedures. The operators will maintain this designation while participating in the study. All operators will continue to wear the dosimeters issued by the catheterization laboratory as part of standard radiation monitoring.

Each operator will be assigned six dosimeters, which will be secured within the cap at the time of assignment. The use of each cap and respective set of dosimeters will be recorded in a log book in the secure cardiac catheterization laboratory and associated with specific cardiac case numbers. Specific factors related to operator radiation exposure for each procedure will be recorded including: operator height, patient weight and BMI, dose area product (DAP), fluoroscopy time, length of procedure, type of procedure, access site, and complexity of procedure as determined by the attending physician. The operators will comment on the comfort of the cap using a semi-quantitative scale and the levels of exposure will be measured from the dosimeters. The operators will also be asked to compare and contrast the study cap with any other attenuating or non-attenuating cap that has been previously worn. At the conclusion of the study, statistical analysis will be performed to determine the differential levels of exposure between the primary and secondary operators, between different sides of the head, and the attenuation ability of the XPF cap. The dosimeters on the outside of the cap will serve as the control in evaluating the attenuating ability of the cap compared to the corresponding dosimeters on the inside. Each dosimeter location on the outside of the cap will be compared to the other locations for both the outside and the inside sets. And finally, the exposure measurements will be compared between the primary and secondary operators for each dosimeter location. The specific factors listed above that affect operator exposure will be taken into account as well.

Study Design

Study Type : Observational
Actual Enrollment : 11 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Brain Radiation Exposure and Attenuation During Invasive Cardiology Procedures.
Study Start Date : January 2013
Primary Completion Date : July 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Intervention Details:
    Device: All subjects are wearing the non-lead attenuation cap (BLOXR)
    The cap is worn by all subjects with dosimeters secured both inside and outside the cap.
    Other Name: Attenuating cap, BLOXR

Outcome Measures

Primary Outcome Measures :
  1. Differential radiation exposure from corresponding locations on the outside and inside of the non-lead attenuating cap. [ Time Frame: Radiation exposure has been ongoing and will be assessed upon dosimeter measurement in within 1 month by an independent radiation monitoring service. ]

Secondary Outcome Measures :
  1. Differential radiation exposure between the left and right sides of the heads of invasive cardiology operators. [ Time Frame: Dosimeters measurement to be read/reported within one month. ]

Other Outcome Measures:
  1. Differential radiation exposure between primary and secondary operators of invasive cardiology procedures. [ Time Frame: Dosimeters measurement to be read/reported within one month. ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
We plan to enroll up to 12 invasive cardiologists routinely performing cardiac catheterization procedures at the UCSD Medical Center, La Jolla campus. We plan to monitor radiation exposure in at least 50 cases for each operator.

Inclusion Criteria:

  • 18 years or older
  • Routinely performing cardiac catheterization procedures as the primary or secondary operators

Exclusion Criteria:

  • Cases with emergent indications including STEMI will be excluded
  • Cases consisting of solely right heart catheterization will be excluded
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01910272

United States, California
University of California, San Diego, Sulpizio Cardiovascular Center
La Jolla, California, United States, 92093
Sponsors and Collaborators
University of California, San Diego
Principal Investigator: Ehtisham Mahmud, MD University of California, San Diego
More Information

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ryan Reeves, MD, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01910272     History of Changes
Other Study ID Numbers: UCSD #120980
First Posted: July 29, 2013    Key Record Dates
Last Update Posted: July 29, 2013
Last Verified: July 2013

Keywords provided by Ryan Reeves, University of California, San Diego:
Radiation attenuation
Invasive cardiac procedures
Cardiac Catheterization