Analysis of Surface EKG Signals to Identify Myocardial Dysfunction in Patients at Risk for Coronary Artery Disease



Status:Completed
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:10/25/2017
Start Date:October 2015
End Date:June 2016

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Multidimensional Wavelet Analysis of Surface Electrocardiogram for Identifying Subclinical Myocardial Dysfunction in Patients at Risk for Coronary Artery Disease

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

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.

Inclusion Criteria:

- Sinus rhythms

- Age>18 years

- Both genders

Exclusion Criteria:

- Acute coronary syndromes(ACS)

- Contraindications to the administration of iodinated contrast

- Pregnancy

- Coronary artery bypass surgery (CABG)

- History of cardiac valvular replacement

- Implanted cardiac pacemaker

- Chest deformities

- Unwilling or unable to provide informed consent for study participation

- Enrolled in another clinical study
We found this trial at
1
site
1428 Madison Ave
New York, New York 10029
(212) 241-6500
Principal Investigator: Partho P Sengupta, MD, DM, FACC, FASE
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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mi
from
New York, NY
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