Ultra-low-dose CACS in a Large Population

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

Clinical Phase

NA

Total Enrollment

301 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-05

Study Completion Date

2021-10-25

Brief Summary

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Radiation exposure to patients from CT for CAC scoring has steadily decreased in recent years. This is mainly achieved through lowering tube currents alongside with the introduction of iterative reconstruction algorithms which allow compensating for increased image noise. However, the greatest radiation dose reduction can be obtained by reducing peak tube voltage. Yet lowering peak tube voltage remains challenging because tissue attenuation is closely related to photon energy, thus rendering the established thresholds for calculating CAC scores (i.e. Agatston scores) incomparable if peak tube voltages other than the standard 120 kilovolt peak (kVp) are applied. The investigators have developed novel tube-adapted thresholds for CAC scoring by CT at 80 kVp and 70-kVp tube voltage and have shown that these novel thresholds are valid, yielding results closely comparable to the standard 120-kVp protocol. The present study aims to optimize application of such low-dose scans in a general population through assessment of the impact of physiological patient parameters on image parameters such as image noise which per se may impact the accuracy and feasibility of ultra-low-dose CAC scoring with reduced tube voltage. Furthermore, the prognostic performance of such low-dose CAC scoring will be elucidated.

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Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Standard and ultra-low-dose CAC scoring

Group Type OTHER

Ultra low-dose CTAC

Intervention Type DIAGNOSTIC_TEST

All patients undergo two non-contrast enhanced CT scans with standard dose (i.e. 120 kVp), one with 80 kVp and one with 70 kVp.

Interventions

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Ultra low-dose CTAC

All patients undergo two non-contrast enhanced CT scans with standard dose (i.e. 120 kVp), one with 80 kVp and one with 70 kVp.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patients referred for a non-contrast enhanced CT scan for CAC scoring
* Male and Female subjects ≥18 years of age,
* Written informed consent

Exclusion Criteria

* Pregnancy or breast-feeding
* CACS of 0 after inclusion of 50 patients with CACS 0 (as assessed visually after the first CT scan, prior to performing the 3 additional study scans)
* History of coronary artery stenting, coronary artery bypass grafting, of implantation of cardiac devices (e.g. valve prosthesis, pacemaker, implantable cardioverter defibrillator etc.)
* Enrolment of the investigator, his/her family members, employees and other dependent persons

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No