Ultra Low Dose CT for CACS and AC of SPECT

NCT ID: NCT02458352

Last Updated: 2019-10-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-10-31

Brief Summary

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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.

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

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Standard dose CT, Ultra-low dose CT

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

Group Type OTHER

Ultra low dose non-contrast enhanced CT

Intervention Type 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

Intervention Type DEVICE

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

Interventions

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Ultra low dose non-contrast enhanced CT

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

Intervention Type DEVICE

Standard dose non-contrast enhanced CT

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Valerie Treyer, PhD

Role: STUDY_DIRECTOR

University of Zurich

Locations

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Department of Nuclear Medicine, University Hospital Zurich

Zurich, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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USZ-2015-0072

Identifier Type: -

Identifier Source: org_study_id

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