MyoVista Measurements in Patients With Atherosclerosis and CAD
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 10/19/2018 |
| Start Date: | September 2015 |
| End Date: | September 2019 |
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.
assessment of myocardial abnormalities by analyzing energy changes at the cellular level of
the myocardium.
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.
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.
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)
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