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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02560168
• Other study ID #: GCO 15-0726
• Secondary ID: Heart Test Labor
• Status: Completed
• Phase: N/A
• First received: September 23, 2015
• Last updated: October 19, 2017
• Start date: October 2015
• Est. completion date: June 2016

Study information

• Verified date: October 2017
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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
• 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).
• Transthoracic Echocardiography

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	Heart Test Laboratories Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Serum electrolytes	Serum electrolytes level to include sodium, potassium, calcium, and magnesium	3 months
Secondary	Serum creatinin level		3 months
Secondary	Serum Brain natriuretic peptide (BNP) level		3 months
Secondary	Serum cardiac enzymes	Serum cardiac enzymes include creatinin kinase MB fraction (CK-MB)	3 months
Secondary	Serum high sensitivity C-reactive protein (hsCRP)		3 months