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The objective of this study is to compare a standard coronary CT angiography scan protocol with conventional image reconstruction with a scan protocol using reduced tube current and a new image reconstruction algorithm. The investigators hypothesize that the image quality of the new scan protocol is not inferior, while radiation dose estimates are reduced by around 30%.
Secondary endpoints of the study include quantitative image quality parameters, prevalence of non-diagnostic studies, prevalence of coronary artery plaques and plaque characteristics (calcified, non-calcified, mixed) and prevalence of follow-up examinations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | Conventional coronary CT angiography using standard reconstruction technique (filtered back projection). |
|
| Intervention group | Experimental | Using the new scan protocol with 30 % less tube current and iterative image reconstruction algorithm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control group | Radiation | Conventional coronary CT angiography using standard reconstruction technique (filtered back projection). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Image quality | Compared with a conventional scan protocol the use of a new scan protocol using iterative image reconstruction and reduced tube current is associated with a comparable diagnostic image quality, while the radiation dose estimates are significantly reduced. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Quantitative image quality parameters | Quantitative image quality parameters, e.g. image noise, signal and contrast intensity, signal- and contrast-to-noise-ratios | 1 month |
| Prevalence of non-diagnostic examinations |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joerg Hausleiter, MD | Contact | 49 89 1218 | 1585 | hausleiter@dhm.mhn.de |
| Simon Deseive, MD | Contact | 49 89 1218 | 0 | deseive@dhm.mhn.de |
| Name | Affiliation | Role |
|---|---|---|
| Joerg Hausleiter, MD | Deutsches Herzzentrum Muenchen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Deutsches Herzzentrum Muenchen | Recruiting | Munich | Bavaria | 80636 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26189118 | Derived | Deseive S, Chen MY, Korosoglou G, Leipsic J, Martuscelli E, Carrascosa P, Mirsadraee S, White C, Hadamitzky M, Martinoff S, Menges AL, Bischoff B, Massberg S, Hausleiter J. Prospective Randomized Trial on Radiation Dose Estimates of CT Angiography Applying Iterative Image Reconstruction: The PROTECTION V Study. JACC Cardiovasc Imaging. 2015 Aug;8(8):888-96. doi: 10.1016/j.jcmg.2015.02.024. Epub 2015 Jul 15. |
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| Intervention group | Radiation | Using the new scan protocol with 30 % less tube current and iterative image reconstruction algorithm. |
|
Prevalence of non-diagnostic examinations in both study arms.
| 1 month |
| Prevalence of coronary artery plaques | Prevalence of coronary artery plaques and coronary artery plaques characteristics (non-calcified, calcified, mixed) in both study arms. | 1 month |
| Prevalence of follow-up examinations | Prevalence of follow-up examinations in both study arms. | 1 month |
| Radiation dose | Radiation dose in both study arms. | 1 month |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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