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

• Conditions: Coronary Artery Disease
• Interventions: 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)

• Registration Number: NCT05245149
• Lead Sponsor: University Hospital Augsburg

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-07
• Study First Submitted: 2021-07-15
• Study First Submitted QC: 2022-02-08
• Last Update Submitted: 2022-02-08
• Study First Posted: 2022-02-17
• Last Update Posted: 2022-02-17
• Study Start: 2022-02-20
• Primary Completion: 2023-08-30
• Study Completion: 2024-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prospective Cohort	Cardiac CTA on a photon-counting detector CT (PCD-CT)	Patients with a clinical indication for coronary CT angiography will undergo this scan on a photon counting detector CT (PCD-CT).
Retrospective Cohort	Cardiac CTA on a regular CT with Energy-Integrating Detector (EID-CT)	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)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Diagnostic Accuracy of Coronary Artery Stenosis Assessment in Comparison with invasive catheter angiography	1 year	Comparison in the subgroups of patients who als undergo invasive catheter angiography