Image Quality and Radiation Dose Associated With Cardiac Scans in Modern CT Scanners

Study Overview
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Brief Summary
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The main objective of this study is to evaluate the dose efficiency of coronary CT angiography (CTA) using a photon counting detector CT (PCD-CT) with the dose efficiency of coronary CT angiography of prior CT generations. 100 patients with a clinical indication for coronary CT angiography will be prospectively enrolled and undergo coronary CTA on a PCD-CT. For comparison, a matched retrospective cohort of 100 patients will be created who had undergone on a prior scanner generation (retrospective cohort).

Official Title
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Prospective Observational Study of Image Quality and Radiation Dose Associated With Cardiac Scans in Modern CT Scanners

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Diagnostic Test: Cardiac CTA on a photon-counting detector CT (PCD-CT)
* Diagnostic Test: Cardiac CTA on a regular CT with Energy-Integrating Detector (EID-CT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: indication for coronary CTA confirmed by board-certified radiologist ('justified indication' according to German/European radiation protection law) AND patient (is able to give informed consent and) has given informed consent. Exclusion Criteria: contraindications to (iodine based) iv contrast material: known allergy to iodine-based iv contrast, acute or high-grade chronic kidney insufficiency with an estimated glomerular filtration rate < 30 ml/min/1.73 m², latent or manifest hyperthyroidism known or suspected pregnancy lactating mothers

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prospective Cohort<br>Patients with a clinical indication for coronary CT angiography will undergo this scan on a photon counting detector CT (PCD-CT). | Diagnostic Test: Cardiac CTA on a photon-counting detector CT (PCD-CT)<br>* Cardiac CTA will be performed on a dual-source photon-counting CT<br>|
| Retrospective Cohort<br>For comparison, a matched retrospective cohort will be created of patients who had undergone coronary CT angiography on prior CT scanner generations (with energy-integrating detector CT, EID-CT) | Diagnostic Test: Cardiac CTA on a regular CT with Energy-Integrating Detector (EID-CT)<br>* Cardiac CTA was performed on a dual-source CT with regular energy-integrating detector (EID-CT)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraluminal Enhancement of Coronary Arteries | measured on thin-slice reconstructions, in Hounsfield units | 1 year | 
| Image Noise | measured on thin-slice reconstructions, in Hounsfield units | 1 year | 
| Overall subjective image quality | as assessed by board-certified and speciality-trained radiologists on a 5-point Likert scale | 1 year | 
| Dose-Length Product (DLP) | Integrative descriptor for the x-ray dose applied during acquisition; can be read out from the scan protocol. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic Accuracy of Coronary Artery Stenosis Assessment in Comparison with invasive catheter angiography | Comparison in the subgroups of patients who als undergo invasive catheter angiography | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spectral CT, Multi-Energy CT, Photon Counting Detector CT, PCD-CT