CT in Calcified Coronary Arteries With Photon Counting Detector

Coronary Stenosis Clinical Trial

— CCT-PCD-1  

Official title:

CT av förkalkade kranskärl Med fotonräknarteknik

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05551351
• Other study ID #: 278326
• Status: Recruiting
• Start date: February 16, 2023
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: Region Örebro County
• Contact: Mats Lidén, MD, PhD
• Phone: +46196020370
• Email: mats.liden[@]regionorebrolan.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Coronary CT angiography is challenging in patients with more than mildly calcified coronary vessels, because of calcium artefacts that prevents evaluation of the lumen. The purpose of the CCT-PCD-1-study is to evaluate the diagnostic accuracy and image quality in coronary CT angiography using a commercially available CT system equipped with a photon counting detector technology. Patients referred for cardiac CT and conventional coronary angiography as part of routine preoperative evaluation before Transcatheter Aortic Valve Implantation (TAVI) will be asked for inclusion in the study. This group of patients has generally a coronary artery calcium burden and perform cardiac CT and coronary angiography as part of routine care. The diagnostic accuracy concerning significant coronary artery stenosis on the preoperative CT will be evaluated with the conventional coronary angiography as reference. Also, CT examination image quality will be evaluated.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Patients referred for cardiac CT AND conventional coronary angiography as part of routine preoperative evaluation.

Exclusion Criteria:

• <65 years old.
• Heart arrhythmia.
• Heart rate >90/min with contraindication against beta blockers.
• Not capable of giving informed consent
• eGFR <30 mL/min/1.73m2

Related Conditions & MeSH terms

• Arteriosclerosis
• Coronary Artery Disease
• Coronary Stenosis
• Myocardial Ischemia

Intervention

Diagnostic Test:
• Cardiac CT with photon counting detector
Cardiac CT including the coronary arteries. The cardiac CT is performed in routine care for the included patients.

Locations

Country	Name	City	State
Sweden	Röntgenkliniken Universitetssjukhuset Örebro	Örebro

Sponsors (1)

Lead Sponsor	Collaborator
Region Örebro County

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy of CT concerning coronary stenosis with conventional angiography as reference	Coronary angiography with or without FFR is performed as part of routine care for included patients. The outcome measure is the agreement between coronary CT and coronary angiography.	1 day. (Coronary angiography is usually performed the same day as cardiac CT.)
Secondary	Image quality	Image quality on CT examination according to European guidelines on quality criteria for computed tomography	1 day. (Image quality is assessed on the performed examination)