MyoVista Measurements in Patients With Atherosclerosis and CAD

NCT02873052 | Completed DMC

• 1 other identifier: 21562-01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease (CAD); Atherosclerosis

Outcome Measures

Primary Outcomes (1)

• Ability of MyoVista to measures subclinical atherosclerosis

  5 Months

Interventions

MyoVista DEVICE

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center: lead
• Heart Test Laboratories, Inc.: collaborator

Study Sites (1)

Los Angeles Biomedical Research Institute

Torrance, California, 90502, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Cholesterol measurements, Inflammatory markers (Interleukin-6 and C-reactive protein).

MeSH Terms

Conditions

Coronary Artery Disease; Atherosclerosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Tess Jackovich

  VP-Business Development

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 29, 2016
• First Posted: August 19, 2016
• Study Start: September 1, 2015
• Primary Completion: September 22, 2019
• Study Completion: February 22, 2020
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)