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

NCT05245149 | Unknown

• 1 other identifier: 21-0383
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Coronary Artery Disease

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Diagnostic Accuracy of Coronary Artery Stenosis Assessment in Comparison with invasive catheter angiography

  1 year

Study Arms (2)

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)

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)

Interventions

Cardiac CTA on a photon-counting detector CT (PCD-CT) DIAGNOSTIC_TEST

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

Prospective Cohort

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

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

Retrospective Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Augsburg: lead

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Florian Schwarz, MD

  University Hospital Augsburg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Florian Schwarz, MD

CONTACT

+49821400; radiologie-studien@uk-augsburg.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: February 17, 2022
• Study Start: February 20, 2022
• Primary Completion: August 30, 2023
• Study Completion: August 30, 2024
• Last Updated: February 17, 2022

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Requests for sharing individual participant data will be considered at the time of publication of the first manuscript containing result data.
• Access Criteria: We plan to share data on request at this point in time.