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

Mount Sinai Health System

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Device: Transthoracic Echocardiography; Device: Computed tomographic coronary angiography; Device: MyoVista device

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02560168

GCO 15-0726

Heart Test Laboratories, Inc. (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Coronary artery disease

Experimental group

Description:

Patients scheduled for computed tomographic coronary angiography (CTA)

Treatment:

Device: MyoVista device

Device: Computed tomographic coronary angiography

Device: Transthoracic Echocardiography