Prospective Randomized Trial On Radiation Dose Estimates Of CT Angiography In Patients Applying Iterative Image Reconstruction Techniques - The PROTECTION V Study -

Study Overview
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Brief Summary
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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.

Official Title
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Prospective Randomized Trial On Radiation Dose Estimates Of CT Angiography In Patients Applying Iterative Image Reconstruction Techniques - The PROTECTION V Study -

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Radiation: Control group
* Radiation: Intervention group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with an indication for a coronary CT angiography (planned evaluation of the coronary arteries) signed informed consent stable sinus rhythm age > 18 years Exclusion Criteria: known allergy to contrast agents. patients with known coronary artery disease pregnancy no stable sinus rhythm coronary ct examinations not focussing on coronary arteries

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Conventional coronary CT angiography using standard reconstruction technique (filtered back projection). | Radiation: Control group<br>* Conventional coronary CT angiography using standard reconstruction technique (filtered back projection).<br>|
| Experimental: Intervention group<br>Using the new scan protocol with 30 % less tube current and iterative image reconstruction algorithm. | Radiation: Intervention group<br>* Using the new scan protocol with 30 % less tube current and iterative image reconstruction algorithm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary artery disease, coronary CT angiography, radiation dose, iterative image reconstruction, detection