CT in Calcified Coronary Arteries With Photon Counting Detector

NCT ID: NCT05551351

Last Updated: 2025-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

29 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-16

Study Completion Date

2024-12-01

Brief Summary

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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

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Conditions

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Coronary Stenosis Calcific Coronary Arteriosclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Cardiac CT with photon counting detector

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Cardiac CT with photon counting detector

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Region Örebro County

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mats Lidén, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Örebro University, Sweden

Locations

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Röntgenkliniken Universitetssjukhuset Örebro

Örebro, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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278326

Identifier Type: -

Identifier Source: org_study_id

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