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The Effectiveness of 4D Image Acquisition and Post-processing With Vios Works

NCT03128268 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2022-10-26

No results posted yet for this study

Summary

This study aims to evaluate the effectiveness of 4D image acquisition and post-processing with Vios Works for the evaluation of 3D images acquired on GE Magnetic Resonance Imaging scanners. Specifically, the investigators propose to evaluate the following:

1. Image acquisition time using traditional 2D and new 4D processing techniques;
2. Image quality for 2D and 4D processing techniques subjectively
3. Post-processing time for the two techniques.
4. Correlation of overall Left ventricular and right ventricular volumes and functions and aortic and pulmonic flow studies using the two techniques.
5. The study will monitor any changes in patient diagnoses or treatment resulting from any differences in interpretations between the two processes.

Conditions

  • Cardiac Disease

Interventions

DEVICE

Imaging software for 4 dimensional images for Cardiac MRI

All enrollees will receive Cardiac MRI scans using Imaging software for 4 dimensional images for Cardiac MRI

Sponsors & Collaborators

  • GE Healthcare

    collaborator INDUSTRY

  • Arterys, Inc.

    collaborator UNKNOWN

  • Northwell Health

    lead OTHER

Principal Investigators

  • Michael Poon, MD · Northwell Health

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-20
Primary Completion
2021-04-26
Completion
2023-06-20
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03128268 on ClinicalTrials.gov