Evaluation of MyoStrain™ in Clinical Practice

November 18, 2019 updated by: University of Kansas Medical Center
Evaluate MyoStrain cardiac MRI pulse sequence in Clinical practice

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Evaluate MyoStrain cardiac MRI pulse sequence in Clinical practice to determine how the use may alter treatment decisions and clinical outcomes in patients who are undergoing cardiac MRI.

Study Type

Observational

Enrollment (Actual)

19

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • The University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Population will consist of patients scheduled for diagnostic testing with cardiac MRI

Description

Inclusion Criteria:

  • Patients already scheduled for diagnostic testing with commercially available imaging modality (cardiac MRI)
  • The patient population will include (but not limited to), those being evaluated for heart disease and heart failure that may be related to vascular disease (coronary artery disease), drug related heart failure (chemotherapy, alcohol), inflammatory systemic conditions (sarcoidosis, amyloidosis, lupus), myocarditis, and/or infectious etiologies
  • Provided written informed consent

Exclusion Criteria:

  • Contraindication to Magnetic Resonance Imaging

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate workflow for MyoStrain testing
Time Frame: Baseline

Survey the CMR interpreter to see how Myostrain impacted their interpretation and survey the referring clinician after receiving the CMR report.

Survey Questions using 5-point Likert and binary reporting scale. The lower numbers represent positive feedback. Example listed below:

CARDIAC MRI INTERPRETATION QUESTIONS FOR READER (CARDIOLOGIST OR RADIOLOGIST)

How easy was it to interpret the additional Myostrain sequence information? 1 2 3 4 5

(1=Very Helpful 2=Helpful 3=Indifferent 4=Unhelpful 5=Very Unhelpful)
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Investigators

  • Principal Investigator: Brian M Everist, MD, The University of Kansas Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2019

Primary Completion (Actual)

November 15, 2019

Study Completion (Actual)

November 15, 2019

Study Registration Dates

First Submitted

January 4, 2019

First Submitted That Met QC Criteria

January 30, 2019

First Posted (Actual)

January 31, 2019

Study Record Updates

Last Update Posted (Actual)

November 19, 2019

Last Update Submitted That Met QC Criteria

November 18, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00142902

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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