Prospective Multicenter Registry On RadiaTion Dose Estimates Of Cardiac CT AngIOgraphy IN Daily Practice in 2017
Completed
Conditions studied: Coronary Artery Disease, Cardiac Disease, Malignancy, Second
In brief
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.
Key facts
- Study ID
- NCT02996903
- Run by
- LMU Klinikum
- People needed
- 4502
- Starts
- 2017-03-01
- Expected to finish
- 2017-12-31
- Last updated by the study team
- 2018-05-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients with a clinical indication for CCTA in order to evaluate the coronary arteries or other cardiac structures
- Patients age > 18 years
- Signed informed consent (if required by local IRB)
You may not qualify if…
- Known allergy to contrast agent
Where it is running
- National Heart, Lung, and Blood Institute — Bethesda, Maryland, United States
- University of British Columbia, Department of Medical Imaging — Vancouver, British Columbia, Canada
- Ludwig-Maximilians-Universitaet Muenchen, Medizinische Klinik I — Munich, Bavaria, Germany
- Technion Israel Institute of Technology, The Ruth and Bruce Rappaport Faculty of Medicine — Haifa, Israel
Full record on ClinicalTrials.gov
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