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

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: MyoVista device; Device: Computed tomographic coronary angiography; Device: Transthoracic Echocardiography

• Registration Number: NCT02560168
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-09-23
• Study First Submitted QC: 2015-09-23
• Study First Posted: 2015-09-25
• Study Start: 2015-10
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-19
• Last Update Posted: 2017-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Sinus rhythms
• Age>18 years
• Both genders

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Coronary artery disease	MyoVista device	Patients scheduled for computed tomographic coronary angiography (CTA)
Coronary artery disease	Computed tomographic coronary angiography	Patients scheduled for computed tomographic coronary angiography (CTA)
Coronary artery disease	Transthoracic Echocardiography	Patients scheduled for computed tomographic coronary angiography (CTA)

Primary Outcome Measures

Name	Time	Method
Colorized waveform	Day 1	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.

Secondary Outcome Measures

Name	Time	Method
Change in coronary plaque burden	Baseline and 3 months	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)
Myocardial wall motion score index (WMSI)	Baseline	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.
Serum electrolytes	3 months	Serum electrolytes level to include sodium, potassium, calcium, and magnesium
Serum cardiac enzymes	3 months	Serum cardiac enzymes include creatinin kinase MB fraction (CK-MB)
Serum creatinin level	3 months
Serum Brain natriuretic peptide (BNP) level	3 months
Serum high sensitivity C-reactive protein (hsCRP)	3 months

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States