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 : October 17, 2018
|Condition or disease||Intervention/treatment|
|Coronary Artery Disease (CAD) Atherosclerosis||Device: MyoVista|
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|
|Official Title:||MyoVista Measurements in Patients With Atherosclerosis and CAD|
|Actual Study Start Date :||September 2015|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||September 2019|
- 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.
- Ability of MyoVista to measures subclinical atherosclerosis [ Time Frame: 5 Months ]
Biospecimen Retention: Samples Without DNA
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
|United States, California|
|Los Angeles Biomedical Research Institute|
|Torrance, California, United States, 90502|
|Study Director:||Tess Jackovich||VP-Business Development|