跳至主要内容
临床试验/NCT02873052
NCT02873052已完成不适用

MyoVista Measurements in Patients With Atherosclerosis and CAD

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2015年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
1
主要终点
Ability of MyoVista to measures subclinical atherosclerosis

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

结局指标

主要结局

Ability of MyoVista to measures subclinical atherosclerosis

时间窗: 5 Months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Matthew J. Budoff

Principal Investigator

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

研究点 (1)

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