CT in Calcified Coronary Arteries With Photon Counting Detector

Terminated

• Conditions: Coronary Stenosis; Calcific Coronary Arteriosclerosis
• Interventions: Diagnostic Test: Cardiac CT with photon counting detector

• Registration Number: NCT05551351
• Lead Sponsor: Region Örebro County

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-13
• Study First Submitted QC: 2022-09-19
• Study First Posted: 2022-09-22
• Study Start: 2023-02-16
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-11
• Last Update Posted: 2025-04-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Coronary CT	Cardiac CT with photon counting detector	The single cohort consists of all patients enrolled in the study. All participants performs cardiac CT and coronary angiography as part of routine care.

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of CT concerning coronary stenosis with conventional angiography as reference	1 day. (Coronary angiography is usually performed the same day as cardiac CT.)	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.

Secondary Outcome Measures

Name	Time	Method
Image quality	1 day. (Image quality is assessed on the performed examination)	Image quality on CT examination according to European guidelines on quality criteria for computed tomography

Trial Locations

Locations (1)

Röntgenkliniken Universitetssjukhuset Örebro; 🇸🇪 Örebro, Sweden