Skip to content

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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05245149
Enrollment
200
Registered
2022-02-17
Start date
2022-02-20
Completion date
2024-08-30
Last updated
2022-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

Spectral CT, Multi-Energy CT, Photon Counting Detector CT, PCD-CT

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).

Interventions

DIAGNOSTIC_TESTCardiac CTA on a photon-counting detector CT (PCD-CT)

Cardiac CTA will be performed on a dual-source photon-counting CT

DIAGNOSTIC_TESTCardiac CTA on a regular CT with Energy-Integrating Detector (EID-CT)

Cardiac CTA was performed on a dual-source CT with regular energy-integrating detector (EID-CT)

Sponsors

University Hospital Augsburg
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Intraluminal Enhancement of Coronary Arteries1 yearmeasured on thin-slice reconstructions, in Hounsfield units
Image Noise1 yearmeasured on thin-slice reconstructions, in Hounsfield units
Overall subjective image quality1 yearas assessed by board-certified and speciality-trained radiologists on a 5-point Likert scale
Dose-Length Product (DLP)1 yearIntegrative descriptor for the x-ray dose applied during acquisition; can be read out from the scan protocol.

Secondary

MeasureTime frameDescription
Diagnostic Accuracy of Coronary Artery Stenosis Assessment in Comparison with invasive catheter angiography1 yearComparison in the subgroups of patients who als undergo invasive catheter angiography

Contacts

Primary ContactFlorian Schwarz, MD
radiologie-studien@uk-augsburg.de+49821400

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026