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

Sponsor

University Hospital Augsburg (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05245149

Collaborator

(none)

200

Enrollment

30.3

Anticipated Duration (Months)

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	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 Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Feb 20, 2022

Anticipated Primary Completion Date :

Aug 30, 2023

Anticipated Study Completion Date :

Aug 30, 2024

Arms and Interventions

Arm	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)

Arm

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)

Outcome Measures

Primary Outcome Measures

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
Overall subjective image quality [1 year]
as assessed by board-certified and speciality-trained radiologists on a 5-point Likert scale
Dose-Length Product (DLP) [1 year]
Integrative descriptor for the x-ray dose applied during acquisition; can be read out from the scan protocol.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University Hospital Augsburg

Investigators

Principal Investigator: Florian Schwarz, MD, University Hospital Augsburg

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital Augsburg

ClinicalTrials.gov Identifier:

NCT05245149

Other Study ID Numbers:

21-0383

First Posted:

Feb 17, 2022

Last Update Posted:

Feb 17, 2022

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by University Hospital Augsburg

Spectral CT

Multi-Energy CT

Photon Counting Detector CT

PCD-CT

Additional relevant MeSH terms:

Coronary Artery Disease

Study Results

No Results Posted as of Feb 17, 2022