Brain Radiation Exposure and Attenuation During Invasive Cardiology Procedures

NCT01910272 | Completed

• 1 other identifier: UCSD #120980
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiation Effects

Keywords

Radiation attenuation; Fluoroscopy; Invasive cardiac procedures; Cardiac Catheterization

Outcome Measures

Primary Outcomes (1)

• Differential radiation exposure from corresponding locations on the outside and inside of the non-lead attenuating cap.

  Radiation exposure has been ongoing and will be assessed upon dosimeter measurement in within 1 month by an independent radiation monitoring service.

Secondary Outcomes (1)

• Differential radiation exposure between the left and right sides of the heads of invasive cardiology operators.

  Dosimeters measurement to be read/reported within one month.

Other Outcomes (1)

• Differential radiation exposure between primary and secondary operators of invasive cardiology procedures.

  Dosimeters measurement to be read/reported within one month.

Interventions

All subjects are wearing the non-lead attenuation cap (BLOXR) DEVICE

The cap is worn by all subjects with dosimeters secured both inside and outside the cap.

Also known as: Attenuating cap, BLOXR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California, San Diego, Sulpizio Cardiovascular Center

La Jolla, California, 92093, United States

Location

Related Publications (8)

• Andreassi MG, Cioppa A, Botto N, Joksic G, Manfredi S, Federici C, Ostojic M, Rubino P, Picano E. Somatic DNA damage in interventional cardiologists: a case-control study. FASEB J. 2005 Jun;19(8):998-9. doi: 10.1096/fj.04-3287fje. Epub 2005 Mar 31.

  PMID: 15802491 BACKGROUND

• Andreassi MG, Foffa I, Manfredi S, Botto N, Cioppa A, Picano E. Genetic polymorphisms in XRCC1, OGG1, APE1 and XRCC3 DNA repair genes, ionizing radiation exposure and chromosomal DNA damage in interventional cardiologists. Mutat Res. 2009 Jun 18;666(1-2):57-63. doi: 10.1016/j.mrfmmm.2009.04.003. Epub 2009 Apr 22.

  PMID: 19393248 BACKGROUND

• Bernardi G, Padovani R, Morocutti G, Vano E, Malisan MR, Rinuncini M, Spedicato L, Fioretti PM. Clinical and technical determinants of the complexity of percutaneous transluminal coronary angioplasty procedures: analysis in relation to radiation exposure parameters. Catheter Cardiovasc Interv. 2000 Sep;51(1):1-9; discussion 10. doi: 10.1002/1522-726x(200009)51:13.0.co;2-k.

  PMID: 10973008 BACKGROUND

• Goni H, Papadopoulou D, Yakoumakis E, Stratigis N, Benos J, Siriopoulou V, Makri T, Georgiou E. Investigation of occupational radiation exposure during interventional cardiac catheterisations performed via radial artery. Radiat Prot Dosimetry. 2005;117(1-3):107-10. doi: 10.1093/rpd/nci763. Epub 2006 Feb 3.

  PMID: 16461487 BACKGROUND

• Kim KP, Miller DL, Balter S, Kleinerman RA, Linet MS, Kwon D, Simon SL. Occupational radiation doses to operators performing cardiac catheterization procedures. Health Phys. 2008 Mar;94(3):211-27. doi: 10.1097/01.HP.0000290614.76386.35.

  PMID: 18301095 BACKGROUND

• Kuon E, Birkel J, Schmitt M, Dahm JB. Radiation exposure benefit of a lead cap in invasive cardiology. Heart. 2003 Oct;89(10):1205-10. doi: 10.1136/heart.89.10.1205.

  PMID: 12975420 BACKGROUND

• Roguin A, Goldstein J, Bar O. Brain tumours among interventional cardiologists: a cause for alarm? Report of four new cases from two cities and a review of the literature. EuroIntervention. 2012 Jan;7(9):1081-6. doi: 10.4244/EIJV7I9A172.

  PMID: 22207231 BACKGROUND

• Reeves RR, Ang L, Bahadorani J, Naghi J, Dominguez A, Palakodeti V, Tsimikas S, Patel MP, Mahmud E. Invasive Cardiologists Are Exposed to Greater Left Sided Cranial Radiation: The BRAIN Study (Brain Radiation Exposure and Attenuation During Invasive Cardiology Procedures). JACC Cardiovasc Interv. 2015 Aug 17;8(9):1197-1206. doi: 10.1016/j.jcin.2015.03.027.

  PMID: 26292583 DERIVED

Study Officials

• Ehtisham Mahmud, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 19, 2013
• First Posted: July 29, 2013
• Study Start: January 1, 2013
• Primary Completion: July 1, 2013
• Last Updated: July 29, 2013

Record last verified: 2013-07

Locations

US (1)