CT in Calcified Coronary Arteries With Photon Counting Detector

NCT05551351 | Terminated

• 1 other identifier: 278326
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Stenosis; Calcific Coronary Arteriosclerosis

Keywords

Cardiac Computed Tomography; Photon Counting Detector

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Image quality

  1 day. (Image quality is assessed on the performed examination)

Study Arms (1)

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

Interventions

Cardiac CT with photon counting detector DIAGNOSTIC_TEST

Cardiac CT including the coronary arteries. The cardiac CT is performed in routine care for the included patients.

Coronary CT

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• \<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

Sponsors & Collaborators

• Region Örebro County: lead

Study Sites (1)

Röntgenkliniken Universitetssjukhuset Örebro

Örebro, Sweden

Location

MeSH Terms

Conditions

Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Mats Lidén, MD, PhD

  Örebro University, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: September 22, 2022
• Study Start: February 16, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 16, 2025

Record last verified: 2025-04

Locations

SE (1)