Skip to main content
OpenTrials
Completed

NCT Number: NCT02458352

Ultra Low Dose CT for CACS and AC of SPECT

The aim of the study is to compare the CACS obtained from standard dose CT to the CACS obtained from ultra-low-dose scans. Additionally, the usefulness of ultra-low-dose CT for AC of myocardial perfusion SPECT will be assessed.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Nuclear Medicine, University Hospital Zurich

Zurich, 8091, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients referred for myocardial perfusion SPECT
  • Male and Female subjects ≥18 years of age,
  • Written informed consent

Exclusion criteria

  • Pregnancy or breast-feeding
  • CACS of 0 after inclusion of 10 patients with CACS 0
  • Stents or implanted cardiac devices (valves, pace makers, ICD)
  • Coronary artery bypass grafts

Treatment and study plan

Ultra low dose non-contrast enhanced CT

Device

Non-contrast enhanced CT for CACS and AC using a novel protocol for ultra low dose radiation dose exposure

Standard dose non-contrast enhanced CT

Device

Clinically indicated non-contrast enhanced CT for CACS and AC according to routine protocol

Primary outcomes

  1. Agreement and Correlation of Coronary Artery Calcium Score Obtained From Ultra-low-dose and Standard CT

    Time frame: 1 days

    CAC and BA limits of agreement between coronary artery calcium score obtained from ultra-low-dose and standard CT.

    Coronary artery calcium (CAC) is a measure for quantification of coronary artery calcification based on non-contrast enhanced CT, ranging from 0 (no calcifications) to infinite. It is an arbitrary unit. Increasing CAC means higher amounts of coronary artery calcifications and is associated with worse prognosis.

    Bland-Altman (BA) analysis is a statistical method to compare two modalities or techniques assessing the same measure. Limits of agreement is defined as +/- twice the standard deviation of the differences between the reference method and the new modality/technique. Broader limits of agreement mean less accurate results obtained by the new modality/techniqe, while a 0 BA limit of agreement would theoretically reflect perfect agreement.

  2. Intra-class Correlation Coefficient Between Segmental Relative Tracer Uptake From SPECT Datasets Reconstructed With AC Maps Based on Ultra-Low-Dose and Standard Dose CT

    Time frame: 1 day

    For every patient, the CT images from 120 and 70 kVp-CT scans were used to create CTAC maps which were then used to reconstruct SPECT images, displayed as a 17-segment model polar plot with normalized percent tracer uptake given for every segment. Intra-class correlation was then applied to compare segmental relative tracer uptake. Analysis and the resulting correlation coefficient of 0.987 basically demonstrates interchangeability between the two datasets.

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

Usefulness of Ultra Low Dose Cardiac CT for Coronary Calcium Scoring and for Attenuation Correction of SPECT

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 1, 2015
Registry last updated
Oct 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.