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PROTECTION-VI
Sponsor study identifier
observational
4,502
4 countries
4
Study Start
March 1, 2017
Actual (reported)Primary Completion
October 31, 2017
Actual (reported)Study Completion
December 31, 2017
Actual (reported)The "Prospective Multicenter Registry On RadiaTion Dose Estimates Of Cardiac CT AngIOgraphy IN Daily Practice in 2017" (PROTECTION-VI) study is a prospective registry and investigator-initiated initiative without third-party funding, which will collect and analyze the radiation dose exposure of Cardiac Computed Tomography Angiographic (CCTA) studies in current daily practice worldwide. Particularly, the study will assess the use of strategies for dose reduction during CCTA. A decade ago, the multicentre observational PROTECTION-I study has revealed that the dose-length-product of CCTA ranges between 568 - 1259 mGy x cm with a median of 885 mGy x cm. This corresponds to an estimated effective dose of approximately 12 mSv. Since then a variety of techniques have been developed and enhanced in order to reduce radiation exposure during CCTA. Recent studies demonstrated feasibility of dramatically reduced effective radiation doses during CCTA (0,1 - 0,3 mSv). This has been executed in small cohorts of patients at scientific expert centers. However, it remains unclear, if such low-level radiation dose exposure may be achieved in clinical routine and if diagnostic image quality is maintained. In order to analyze the magnitude of radiation dose exposure of CCTA in today's clinical practice and the current use of dose-saving techniques, we designed the PROTECTION-VI study. Eventually, this study may contribute to further improving radiation dose exposure for patients undergoing CCTA.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2017
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 13, 2016
Actual (reported)December 19, 2016
Actual (reported)March 1, 2017
Actual (reported)October 31, 2017
Actual (reported)December 31, 2017
Actual (reported)Radiation dose estimates of cardiac CT angiographies in daily practice
Assessment after CT scan by radiologist or technical assistant, documented on questionnaire.
Baseline
Use of dose-saving strategies
Baseline
Assessment of CCTA image quality in relation to radiation dose
Baseline
Patients undergoing Cardiac Computed Tomography Angiography (CCTA) in clinical routine.
National Heart, Lung, and Blood Institute
Bethesda, Maryland, 20892-1061, United States
University of British Columbia, Department of Medical Imaging
Vancouver, British Columbia, Canada
Ludwig-Maximilians-Universitaet Muenchen, Medizinische Klinik I
Munich, Bavaria, 808303, Germany
Technion Israel Institute of Technology, The Ruth and Bruce Rappaport Faculty of Medicine
Haifa, Israel
Stocker TJ, Leipsic J, Hadamitzky M, Chen MY, Rubinshtein R, Deseive S, Heckner M, Bax JJ, Kitagawa K, Marques H, Schmermund A, Silva C, Mahmarian J, Kang JW, Grove EL, Lesser J, Massberg S, Hausleiter J. Application of Low Tube Potentials in CCTA: Results From the PROTECTION VI Study. JACC Cardiovasc Imaging. 2020 Feb;13(2 Pt 1):425-434. doi: 10.1016/j.jcmg.2019.03.030. Epub 2019 Jun 12.
4,502 participants (actual enrollment reported by the registry).
First Submitted
December 13, 2016
First Posted
December 19, 2016
Study Start
March 1, 2017
Actual (reported)Sufficient result of the first CCTA scan or need for repeated scans
Baseline
Cardiac CT scan length and relationship between scan and heart length
Baseline
Comparison of dose estimates between different continents, CT vendors and CT systems
Baseline
Contact the study team to confirm eligibility.
Primary Completion
October 31, 2017
Actual (reported)Study Completion
December 31, 2017
Actual (reported)Last Updated
May 15, 2018
Record last verified: 2018-05
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Source: ClinicalTrials.gov.
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