Evaluation of MyoStrain™ in Clinical Practice

Completed

• Conditions: Amyloidosis; Cardiac Failure; Lupus; Drug Toxicity; Coronary Artery Disease; Sarcoidosis; Myocarditis

• Registration Number: NCT03825224
• Lead Sponsor: University of Kansas Medical Center

Brief Summary

Evaluate MyoStrain cardiac MRI pulse sequence in Clinical practice

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 Timeline

• Study First Submitted: 2019-01-04
• Study First Submitted QC: 2019-01-30
• Study First Posted: 2019-01-31
• Study Start: 2019-04-15
• Status Verified: 2019-11
• Primary Completion: 2019-11-15
• Study Completion: 2019-11-15
• Last Update Submitted: 2019-11-18
• Last Update Posted: 2019-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate workflow for MyoStrain testing	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)

Trial Locations

Locations (1)

The University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States