CCT-PCD-1: CT in Calcified Coronary Arteries With Photon Counting Detector

Sponsor
Region Örebro County (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05551351
Collaborator
(none)
75
23

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Cardiac CT with photon counting detector

Study Design

Study Type:
Observational
Anticipated Enrollment :
75 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
CT av förkalkade kranskärl Med fotonräknarteknik
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
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.

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Region Örebro County

Investigators

  • Principal Investigator: Mats Lidén, MD, PhD, Örebro University, Sweden

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Region Örebro County
ClinicalTrials.gov Identifier:
NCT05551351
Other Study ID Numbers:
  • 278326
First Posted:
Sep 22, 2022
Last Update Posted:
Sep 22, 2022
Last Verified:
Sep 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Region Örebro County
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 22, 2022