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

April 18, 2024 updated by: Region Örebro County

CT av förkalkade kranskärl Med fotonräknarteknik

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Sweden
      • Örebro, Sweden
        • Recruiting
        • Röntgenkliniken Universitetssjukhuset Örebro
        • Contact:
          • Mats Lidén, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population are at least 65 years old with an expected median age of ~80 years. This group of patients has generally a high coronary artery calcium burden which prevents conventional cardiac CT from evaluation of the coronary arteries.

Since cardiac CT and coronary artery angiography is performed as part of routine care in this patient cohort, no extra examinations are needed for the reference measure of the primary outcome.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day. (Coronary angiography is usually performed the same day as cardiac CT.)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 day. (Image quality is assessed on the performed examination)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Örebro County

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

September 13, 2022

First Submitted That Met QC Criteria

September 19, 2022

First Posted (Actual)

September 22, 2022

Study Record Updates

Last Update Posted (Estimated)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 278326

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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