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Evaluation of MyoStrain™ in Clinical Practice

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ClinicalTrials.gov Identifier: NCT03825224
Recruitment Status : Not yet recruiting
First Posted : January 31, 2019
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
University of Kansas Medical Center

Brief Summary:
Evaluate MyoStrain cardiac MRI pulse sequence in Clinical practice

Condition or disease Intervention/treatment
Cardiac Failure Coronary Artery Disease Sarcoidosis Amyloidosis Lupus Myocarditis Drug Toxicity Procedure: Diagnostic Test: Myostrain

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
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of MyoStrain™ in Clinical Practice
Estimated Study Start Date : February 4, 2019
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : February 1, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: Diagnostic Test: Myostrain
    This test measures the contraction of the heart muscle in one to three heartbeats per plane. It's a pulse sequence that produces images that reveal the underlying contraction fo the muscle of a healthy heart and associated weaknesses in case of disease.


Primary Outcome Measures :
  1. 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)




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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Population will consist of patients scheduled for diagnostic testing with cardiac MRI
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03825224


Contacts
Contact: Carissa Walter, MPH 913-945-7450 cwalter2@kumc.edu
Contact: Lucy Vu, BS 9139457369 lvu4@kumc.edu

Locations
United States, Kansas
The University of Kansas Medical Center Not yet recruiting
Kansas City, Kansas, United States, 66160
Contact: Carissa Walter, MPH    913-945-7450    cwalter2@kumc.edu   
Contact: Lucy Vu, BS    913-945-7369    lvu4@kumc.edu   
Sponsors and Collaborators
University of Kansas Medical Center
Investigators
Principal Investigator: Brian M Everist, MD The University of Kansas Medical Center
  Study Documents (Full-Text)

Documents provided by University of Kansas Medical Center:
Study Protocol  [PDF] December 4, 2018


Publications:

Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT03825224     History of Changes
Other Study ID Numbers: STUDY00142902
First Posted: January 31, 2019    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Keywords provided by University of Kansas Medical Center:
MRI
SENC MyoStrain

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Amyloidosis
Sarcoidosis
Myocarditis
Heart Failure
Drug-Related Side Effects and Adverse Reactions
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Proteostasis Deficiencies
Metabolic Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Cardiomyopathies
Chemically-Induced Disorders