Clinical trial · Observational
Prospective Multicenter Registry On RadiaTion Dose Estimates Of Cardiac CT AngIOgraphy IN Daily Practice in 2017
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cardiac Disease | — | UNRESOLVED | — |
| Coronary Artery Disease | — | UNRESOLVED | — |
| Malignancy, Second | Second Primary Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Radiation dose estimates of cardiac CT angiographies in daily practice
- timeFrame
- Baseline
- description
- Assessment after CT scan by radiologist or technical assistant, documented on questionnaire.
Secondary outcomes (5)
- measure
- Use of dose-saving strategies
- timeFrame
- Baseline
- description
- Use of Low tube potential imaging, Low tube current imaging, Automated Exposure Control, ECG-controlled tube current modulation (dose pulsing), Iterative image reconstruction techniques and Scan protocols (Prospective ECG-triggered axial scanning technique, Prospective ECG-triggered high-pitch spiral acquisition) will be assessed in the Core Lab according to information given by the CT-examiner on a questionnaire.
- measure
- Assessment of CCTA image quality in relation to radiation dose
- timeFrame
- Baseline
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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) Exclusion Criteria: * Known allergy to contrast agent
References
Publications (1)
- DERIVEDStocker 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. PMID 31202772