Ultra Low Dose CT for CACS and AC of SPECT

NCT02458352 | Completed Results DMC

• 1 other identifier: USZ-2015-0072
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (2)

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

  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.

  1 days

• 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

  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.

  1 day

Study Arms (1)

Standard dose CT, Ultra-low dose CT

OTHER

Standard dose non-contrast enhanced CT (clinically indicated) and Ultra low dose non-contrast enhanced CT (as part of the trial)

Device: Ultra low dose non-contrast enhanced CT; Device: Standard dose non-contrast enhanced CT

Interventions

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 CT, Ultra-low dose CT

Standard dose non-contrast enhanced CT DEVICE

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

Standard dose CT, Ultra-low dose CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnancy or breast-feeding
• Stents or implanted cardiac devices (valves, pace makers, ICD)
• Coronary artery bypass grafts

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Department of Nuclear Medicine, University Hospital Zurich

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Results Point of Contact

• Title: Dr. Ronny Buechel
• Organization: University Hospital Zurich

ronny.buechel@usz.ch

0041442551059

Study Officials

• Valerie Treyer, PhD

  University of Zurich

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2015
• First Posted: June 1, 2015
• Study Start: November 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 18, 2019
• Results First Posted: October 18, 2019

Record last verified: 2019-09

Locations

CH (1)