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

NCT03128268 | Active Not Recruiting FDA Device

• 1 other identifier: 16-845-LHH
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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. 1.Image acquisition time using traditional 2D and new 4D processing techniques;
2. 2.Image quality for 2D and 4D processing techniques subjectively
3. 3.Post-processing time for the two techniques.
4. 4.Correlation of overall Left ventricular and right ventricular volumes and functions and aortic and pulmonic flow studies using the two techniques.
5. 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

Outcome Measures

Primary Outcomes (2)

• 2D imaging findings and medical diagnoses resulting from images.

  Investigators will count the number of study outcomes documented that are related to patient treatment.

  Investigators are expected to interpret the 2D images in one sitting requiring 15 minutes to three hours, depending on exam complexity. The investigator will complete the scan review within 1 day to 1 month of the exam date.

• 4D imaging findings and medical diagnoses resulting from images.

  Investigators will count the number of study outcomes documented that are related to patient treatment.

  Investigators are expected to interpret the 4D images in one sitting requiring 15 minutes to three hours, depending on exam complexity. The investigator will complete the scan review within 1 day to 1 month of the exam date.

Secondary Outcomes (10)

• 2D Time to scan acquisition

  The 2D scan time will be from the time the 2D patient scan starts to the time the 2D patient scan ends. These will be measured on the patient's scheduled scan date.

• Time to 2D scan interpretation

  The time required for the reader to interpret scan for 2D and to document results. Within one month of scan completion. Reader is expected to interpret each scan in 1 to 3 hours.

• Intra-reader reliability

  The reader will record all findings from each scan immediately upon completion of scan interpretation. Findings should be recorded within a month of the exam.

• Image quality

  The reader will record an image score for each exam during interpretation of the scan. The reader will record an image score within one month of scan completion date.

• 2D patient recommended treatments

  The reader will recommend follow-up patient care for each patient based upon completion of the exam interpretation. The reader will record all recommendations within one month of the exam.

Study Arms (1)

All Enrollees

EXPERIMENTAL

Intervention: Diagnostic test All enrollees will receive a 4D MRI as a research intervention using imaging software for 4 dimensional images for Cardiac MRI

Device: Imaging software for 4 dimensional images for Cardiac MRI

Interventions

Imaging software for 4 dimensional images for Cardiac MRI DEVICE

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

All Enrollees

Eligibility Criteria

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

You may qualify if:

• years of age or older
• with a valid prescription for Cardiac MRI for the following: Congenital heart disease/Shunts, Valvular heart disease, Pulmonary Hypertension, Aortic Disease, Hypertrophic Cardiomyopathy (HCM)
• receiving Standard of Care services at the MRI Center
• consent to participate in the 4D trial

You may not qualify if:

• Patients with any of the following will be excluded:
• Pacemaker or ICD implanted
• ICDs implanted
• Temporary Pacemakers (e.g. transvenous temporary wires)
• Leads that are abandoned (capped or retained leads not attached to device)
• Non-transvenous leads (e.g. epicardial leads)
• Leads that have no fixation (e.g. floating leads)
• A lead that is known to be fractured
• Any other metallic objects that, in the opinion of the safety officer would compromise patient safety

Sponsors & Collaborators

• Northwell Health: lead
• GE Healthcare: collaborator
• Arterys, Inc.: collaborator

Study Sites (1)

Northwell Health Imaging at Greenwich Village: a Division of Lenox Hill Hospital

New York, New York, 10011, United States

Location

Related Publications (7)

• Okada RD, Lim YL, Rothendler J, Boucher CA, Block PC, Pohost GM. Split dose thallium-201 dipyridamole imaging: a new technique for obtaining thallium images before and immediately after an intervention. J Am Coll Cardiol. 1983 May;1(5):1302-10. doi: 10.1016/s0735-1097(83)80144-2. No abstract available.

  PMID: 6833669 BACKGROUND

• Vasanawala SS, Hanneman K, Alley MT, Hsiao A. Congenital heart disease assessment with 4D flow MRI. J Magn Reson Imaging. 2015 Oct;42(4):870-86. doi: 10.1002/jmri.24856. Epub 2015 Feb 24.

  PMID: 25708923 BACKGROUND

• Hsiao A, Alley MT, Massaband P, Herfkens RJ, Chan FP, Vasanawala SS. Improved cardiovascular flow quantification with time-resolved volumetric phase-contrast MRI. Pediatr Radiol. 2011 Jun;41(6):711-20. doi: 10.1007/s00247-010-1932-z. Epub 2011 Jan 11.

  PMID: 21221566 BACKGROUND

• Hsiao A, Lustig M, Alley MT, Murphy M, Chan FP, Herfkens RJ, Vasanawala SS. Rapid pediatric cardiac assessment of flow and ventricular volume with compressed sensing parallel imaging volumetric cine phase-contrast MRI. AJR Am J Roentgenol. 2012 Mar;198(3):W250-9. doi: 10.2214/AJR.11.6969.

  PMID: 22358022 BACKGROUND

• Hsiao A, Lustig M, Alley MT, Murphy MJ, Vasanawala SS. Evaluation of valvular insufficiency and shunts with parallel-imaging compressed-sensing 4D phase-contrast MR imaging with stereoscopic 3D velocity-fusion volume-rendered visualization. Radiology. 2012 Oct;265(1):87-95. doi: 10.1148/radiol.12120055. Epub 2012 Aug 24.

  PMID: 22923717 BACKGROUND

• Uretsky S, Gillam L, Lang R, Chaudhry FA, Argulian E, Supariwala A, Gurram S, Jain K, Subero M, Jang JJ, Cohen R, Wolff SD. Discordance between echocardiography and MRI in the assessment of mitral regurgitation severity: a prospective multicenter trial. J Am Coll Cardiol. 2015 Mar 24;65(11):1078-88. doi: 10.1016/j.jacc.2014.12.047.

  PMID: 25790878 BACKGROUND

• Dyverfeldt P, Bissell M, Barker AJ, Bolger AF, Carlhall CJ, Ebbers T, Francios CJ, Frydrychowicz A, Geiger J, Giese D, Hope MD, Kilner PJ, Kozerke S, Myerson S, Neubauer S, Wieben O, Markl M. 4D flow cardiovascular magnetic resonance consensus statement. J Cardiovasc Magn Reson. 2015 Aug 10;17(1):72. doi: 10.1186/s12968-015-0174-5.

  PMID: 26257141 BACKGROUND

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Michael Poon, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Non-invasive Cardiac Imaging

Model Details: Each participant will receive tradition 2D Cardiac imaging as ordered per standard of care. Then, the participant will receive a 4D image, requiring 6 to 10 additional minutes in the MRI scanner. The 2D and 4D images will be interpreted by readers blinded to the results of the alternate modality. Inter- and intra-reader reliability will be assessed.

Study Record Dates

• First Submitted: April 3, 2017
• First Posted: April 25, 2017
• Study Start: February 20, 2018
• Primary Completion: April 26, 2021
• Study Completion: June 20, 2023
• Last Updated: October 26, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)