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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: 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)

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Florian Schwarz, MD; Phone Number: 2441 +49821400; Email: radiologie-studien@uk-augsburg.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients who are at least 18 years of age with a clincially indication for a coronary CTA scan. Indication ('justified indication' according to German/European radiation protection law) must be confirmed by a board-certified radiologist.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Prospective Cohort; 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); Cardiac CTA will be performed on a dual-source photon-counting CT
Retrospective Cohort; 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); Cardiac CTA was performed on a dual-source CT with regular energy-integrating detector (EID-CT)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital Augsburg
• Investigators: Principal Investigator: Florian Schwarz, MD, University Hospital Augsburg

Study record dates

Study Major Dates

• Study Start (Anticipated): February 20, 2022
• Primary Completion (Anticipated): August 30, 2023
• Study Completion (Anticipated): August 30, 2024

Study Registration Dates

• First Submitted: July 15, 2021
• First Submitted That Met QC Criteria: February 8, 2022
• First Posted (Actual): February 17, 2022

Study Record Updates

• Last Update Posted (Actual): February 17, 2022
• Last Update Submitted That Met QC Criteria: February 8, 2022
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Spectral CT; Multi-Energy CT; Photon Counting Detector CT; PCD-CT
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: 21-0383

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: We plan to share individual participant data upon request (pending final approval by the data protection officer of the university hospital).
• IPD Sharing Time Frame: Requests for sharing individual participant data will be considered at the time of publication of the first manuscript containing result data.
• IPD Sharing Access Criteria: We plan to share data on request at this point in time.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No