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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05245149
• Other study ID #: 21-0383
• Status: Not yet recruiting
• Start date: February 20, 2022
• Est. completion date: August 30, 2024

Study information

• Verified date: July 2021
• Source: University Hospital Augsburg
• Contact: Florian Schwarz, MD
• Phone: +49821400
• Email: radiologie-studien[@]uk-augsburg.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: August 30, 2024
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Diagnostic Test:
• Cardiac CTA on a photon-counting detector CT (PCD-CT)
Cardiac CTA will be performed on a dual-source photon-counting CT
• Cardiac 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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Augsburg

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraluminal Enhancement of Coronary Arteries	measured on thin-slice reconstructions, in Hounsfield units	1 year
Primary	Image Noise	measured on thin-slice reconstructions, in Hounsfield units	1 year
Primary	Overall subjective image quality	as assessed by board-certified and speciality-trained radiologists on a 5-point Likert scale	1 year
Primary	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	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