Ignite Creation Date:
2024-05-06 @ 8:59 AM
Last Modification Date:
2024-10-26 @ 12:08 PM
Study NCT ID:
NCT02873052
Status:
COMPLETED
Last Update Posted:
2020-02-25
First Post:
2016-06-29
Brief Title:
MyoVista Measurements in Patients With Atherosclerosis and CAD
Sponsor:
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Organization:
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Study Overview
Official Title:
MyoVista Measurements in Patients With Atherosclerosis and CAD
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None