Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2026-01-22 @ 9:32 AM
Study NCT ID:
NCT02560168
Status:
COMPLETED
Last Update Posted:
2017-10-23
First Post:
2015-09-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis of Surface EKG Signals to Identify Myocardial Dysfunction in Patients at Risk for Coronary Artery Disease
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
Study Overview
Official Title:
Multidimensional Wavelet Analysis of Surface Electrocardiogram for Identifying Subclinical Myocardial Dysfunction in Patients at Risk for Coronary Artery Disease
Status:
COMPLETED
Status Verified Date:
2017-10
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:
1. The MyoVista device is capable of detecting surface electrocardiogram signals and sensitive in detecting coronary artery disease compared to traditional computed tomography angiography (CTA)
2. Electrophysiological signals at the cellular level of myocardium are related to specific patterns on the MyoVista device
3. Changes in MyoVista device output and can indicative of future CAD outcomes and need for revascularization
2. Electrophysiological signals at the cellular level of myocardium are related to specific patterns on the MyoVista device
3. Changes in MyoVista device output and can indicative of future CAD outcomes and need for revascularization
Detailed Description:
Background Myocardial ischemia is caused by myocardial oxygen supply and demand mismatch. Despite that coronary artery disease (CAD) is the major cause of myocardial ischemia, the symptoms may occur even in the absence of significant CAD. One of the mechanisms suggested for myocardial ischemia in these patients is microvascular ischemia (i.e. mismatch in microscopic vessels), affecting the myocardium (i.e. heart muscle) at the cellular level.
A novel electrocardiographic recording method, the iECG is capable of capturing and amplifying signals from the cellular level that are much lower biologic signals 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.
Specific Aims
Aim#1: Study the feasibility of detection of CAD using iECG compared to computed tomographic coronary angiography (CTA).
Aim#2: Study the association between patterns of iECG and myocardial dysfunction in patients without CAD compared to echocardiography.
Aim#3: Study the effect of changes in iECG output on future outcomes of CAD and need for revascularization.
A novel electrocardiographic recording method, the iECG is capable of capturing and amplifying signals from the cellular level that are much lower biologic signals 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.
Specific Aims
Aim#1: Study the feasibility of detection of CAD using iECG compared to computed tomographic coronary angiography (CTA).
Aim#2: Study the association between patterns of iECG and myocardial dysfunction in patients without CAD compared to echocardiography.
Aim#3: Study the effect of changes in iECG output on future outcomes of CAD and need for revascularization.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| Heart Test Laboratories, Inc. | OTHER | Icahn School of Medicine at Mount Sinai | View |