MyoVista Measurements in Patients With Atherosclerosis and CAD

October 10, 2024 updated by: Matthew J. Budoff, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
The MyoVista system is a novel electrocardiogram technology that provides non-invasive assessment of myocardial abnormalities by analyzing energy changes at the cellular level of the myocardium.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The MyoVista iECG Electrocardiograph is a diagnostic device used to process electrical signals transmitted through electrocardiograph electrodes and to detect ischemia abnormalities based on electrical waveform, patient data, demographics, algorithmic sensitivity and software based informatics. The MyoVista provides the clinician with a standard ECG conventional waveform, along with an additional report derived from the proprietary informatics exclusive to the MyoVista.

The device holds a lot of promise for early intervention to properly diagnose and treat patients under risk timely and effectively. The MyoVista captures and amplifies signals from the myocardial tissue. These signals are then processed and compared to an algorithm that looks for certain changes occurring in these processed waveforms. The changes that have been identified occur much sooner than those processed by a traditional electrocardiogram (ECG). These recordings focus on early detection of myocardial abnormalities by non-linear analysis of electrical activity and physiological phenomenon. This novel assessment might be capable of detecting subclinical myocardial dysfunction in a variety of heart diseases.

The study would compare MyoVista results to subclinical measures of atherosclerosis (CAC and CT angiography) in 200 subjects at risk for coronary disease. Correlations between the MyoVista reading and the presence of calcified plaque, soft plaque, CTA stenosis, will be determined.

This study has the potential to confirm MyoVista as a reliable and sensitive marker of atherosclerosis. Findings may provide a strong indication for the value of a MyoVista test to confirm CAD in clinical practice, and for the clinical application of MyoVista in management of coronary disease and atherosclerosis.

Study Type

Observational

Enrollment (Actual)

200

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
    • California
      • Torrance, California, United States, 90502
        • Los Angeles Biomedical Research Institute

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients undergoing cardiac CT for clinical reasons in the outpatient center.

Description

Inclusion Criteria:

  • Male or female gender
  • From (and inclusive of) ages of 18 to 80 years
  • Body mass index (BMI) between 18 and 39.9 (kg/m2)
  • Able to lie (supine) still comfortably on the back for at least 20 minutes

Exclusion Criteria:

  • Known history of cancer, other than non-melanoma skin cancer
  • Known history of heart disease or heart rhythm abnormalities
  • Known history of cardiovascular disease
  • Known history of Peripheral Artery Disease (PAD)
  • Known history of claudication
  • History of amputation or loss of limb(s)

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ability of MyoVista to measures subclinical atherosclerosis
Time Frame: 5 Months
5 Months

Collaborators and Investigators

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

Sponsor

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Collaborators

Heart Test Laboratories, Inc.

Investigators

  • Study Director: Tess Jackovich, VP-Business Development

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)

September 1, 2015

Primary Completion (Actual)

September 22, 2019

Study Completion (Actual)

February 22, 2020

Study Registration Dates

First Submitted

June 29, 2016

First Submitted That Met QC Criteria

August 16, 2016

First Posted (Estimated)

August 19, 2016

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 10, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21562-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be tabulated and analysed. Study site will not share any of the subject identifiers.

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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