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

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

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: MyoVista device; Device: Computed tomographic coronary angiography; Device: Transthoracic Echocardiography

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Coronary artery disease; Patients scheduled for computed tomographic coronary angiography (CTA)

Device: MyoVista device; MyoVista device is a standard EKG device with additional capabilities in detecting cellular level myocardial electrophysiological signals. The device involves placing leads on the chest, similar to a traditional EKG device; Other Names: iECG; Device: Computed tomographic coronary angiography; Traditional method of detecting coronary artery disease. CTA will be performed using 64-detector row or higher scanners with electrocardiographic gating in accordance with the Society of Cardiovascular Computed Tomography (SCCT) guidelines. Approximately 80 to 100 ml of intravenous contrast, followed by 50 to 80 ml of saline, will be administered at a rate of 5 ml/s via a power injector through an antecubital vein (on forearm near the elbow).; Other Names: CTA; Device: Transthoracic Echocardiography; Other Names: Echocardiogram

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Colorized waveform	Spectrum analysis to represent levels and locations of cellular energy and automates the analysis into a simple indication of the level of myocardial abnormality if present.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in coronary plaque burden	Change in coronary plaque burden at 3 months compared to baseline. Coronary plaque burden will be assessed by assigning a score (0 to 5) according to the SCCT guidelines (0, Normal: absence of plaque and no luminal stenosis; 1, Minimal: plaque with <25% stenosis; 2, Mild: 25% to 49% stenosis; 3, Moderate: 50%to 69% stenosis; 4, Severe: 70% to 99% stenosis; 5, Complete occlusion)	Baseline and 3 months
Myocardial wall motion score index (WMSI)	Myocardial wall motion score index (WMSI) will be obtained by dividing the left ventricle into 16 segments7. Each of the segments will be assigned a score that is based on myocardial thickening (1 for Normal or hyperkinetic, 2 for hypokinetic, 3 for akinetic, 4 for dyskinesis, 5 for aneurysmal dilatation). WMSI will be calculated as the sum of scores divided by the number of segments visualized.	Baseline
Serum electrolytes	Serum electrolytes level to include sodium, potassium, calcium, and magnesium	3 months
Serum creatinin level		3 months
Serum Brain natriuretic peptide (BNP) level		3 months
Serum cardiac enzymes	Serum cardiac enzymes include creatinin kinase MB fraction (CK-MB)	3 months
Serum high sensitivity C-reactive protein (hsCRP)		3 months

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: Heart Test Laboratories, Inc.
• Investigators: Principal Investigator: Partho P Sengupta, MD, DM, FACC, FASE, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: September 23, 2015
• First Submitted That Met QC Criteria: September 23, 2015
• First Posted (Estimate): September 25, 2015

Study Record Updates

• Last Update Posted (Actual): October 23, 2017
• Last Update Submitted That Met QC Criteria: October 19, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Coronary artery disease; iECG; MyoVista; Heart Test Labs; Wavelet analysis; Surface electrocardiogram
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: GCO 15-0726; Heart Test Laboratories, Inc. (Other Identifier: Icahn School of Medicine at Mount Sinai)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes