Brain Radiation Exposure and Attenuation During Invasive Cardiology Procedures (BRAIN)
Brain Radiation Exposure and Attenuation During Invasive Cardiology Procedures.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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California
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La Jolla、California、アメリカ、92093
- University of California, San Diego, Sulpizio Cardiovascular Center
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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Differential radiation exposure from corresponding locations on the outside and inside of the non-lead attenuating cap.
時間枠:Radiation exposure has been ongoing and will be assessed upon dosimeter measurement in within 1 month by an independent radiation monitoring service.
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Radiation exposure has been ongoing and will be assessed upon dosimeter measurement in within 1 month by an independent radiation monitoring service.
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Differential radiation exposure between the left and right sides of the heads of invasive cardiology operators.
時間枠:Dosimeters measurement to be read/reported within one month.
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Dosimeters measurement to be read/reported within one month.
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その他の成果指標
結果測定 |
時間枠 |
|---|---|
|
Differential radiation exposure between primary and secondary operators of invasive cardiology procedures.
時間枠:Dosimeters measurement to be read/reported within one month.
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Dosimeters measurement to be read/reported within one month.
|
協力者と研究者
出版物と役立つリンク
一般刊行物
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- UCSD #120980
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