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MyoVista Measurements in Patients With Atherosclerosis and CAD

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ClinicalTrials.gov Identifier: NCT02873052
Recruitment Status : Enrolling by invitation
First Posted : August 19, 2016
Last Update Posted : February 2, 2018
Sponsor:
Collaborator:
Heart Test Laboratories Inc.
Information provided by (Responsible Party):
Los Angeles Biomedical Research Institute

Brief Summary:
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.

Condition or disease Intervention/treatment
Coronary Artery Disease (CAD) Atherosclerosis Device: MyoVista

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
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: MyoVista Measurements in Patients With Atherosclerosis and CAD
Actual Study Start Date : September 2015
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis
U.S. FDA Resources


Intervention Details:
    Device: MyoVista
    The clinical set up of MyoVista™ is identical to that of a traditional 12-lead ECG but it obtains and processes signal information in a way that permits much greater resolution of the electrical activity associated with the myocardium MyoVista.


Primary Outcome Measures :
  1. Ability of MyoVista to measures subclinical atherosclerosis [ Time Frame: 5 Months ]

Biospecimen Retention:   Samples Without DNA
Cholesterol measurements, Inflammatory markers (Interleukin-6 and C-reactive protein).


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients undergoing cardiac CT for clinical reasons in the outpatient center.
Criteria

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)

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): NCT02873052


Locations
United States, California
Los Angeles Biomedical Research Institute
Torrance, California, United States, 90502
Sponsors and Collaborators
Los Angeles Biomedical Research Institute
Heart Test Laboratories Inc.
Investigators
Study Director: Tess Jackovich VP-Business Development

Responsible Party: Los Angeles Biomedical Research Institute
ClinicalTrials.gov Identifier: NCT02873052     History of Changes
Other Study ID Numbers: 21562-01
First Posted: August 19, 2016    Key Record Dates
Last Update Posted: February 2, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be tabulated and analysed. Study site will not share any of the subject identifiers.

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Atherosclerosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases