Clinical trial NCT02873052: MyoVista Measurements in Patients With Atherosclerosis and CAD
Official title: MyoVista Measurements in Patients With Atherosclerosis and CAD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease (CAD)
Atherosclerosis
Lead sponsor: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Sponsor class: OTHER
Collaborators: name: Heart Test Laboratories, Inc.
First posted: 2016-08-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing cardiac CT for clinical reasons in the outpatient center.

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.

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.

Eligibility 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)

Primary outcomes:
measure: Ability of MyoVista to measures subclinical atherosclerosis
timeFrame: 5 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Torrance
country: United States
facility: Los Angeles Biomedical Research Institute
state: California
Study officials:
affiliation: VP-Business Development
name: Tess Jackovich
role: STUDY_DIRECTOR
References: