CT in Calcified Coronary Arteries With Photon Counting Detector

Overview

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.

Full Title of Study: “CT av förkalkade kranskärl Med fotonräknarteknik”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 2024

Interventions

  • 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.

Arms, Groups and Cohorts

  • Coronary CT
    • The single cohort consists of all patients enrolled in the study. All participants performs cardiac CT and coronary angiography as part of routine care.

Clinical Trial Outcome Measures

Primary Measures

  • Diagnostic accuracy of CT concerning coronary stenosis with conventional angiography as reference
    • Time Frame: 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 Measures

  • Image quality
    • Time Frame: 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 65 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Region Örebro County
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Mats Lidén, MD, PhD, Principal Investigator, Örebro University, Sweden
  • Overall Contact(s)
    • Mats Lidén, MD, PhD, +46196020370, mats.liden@regionorebrolan.se

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