Analysis of Surface EKG Signals to Identify Myocardial Dysfunction in Patients at Risk for Coronary Artery Disease
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MyoVista device
Computed tomographic coronary angiography
Transthoracic Echocardiography
Sponsored by
About this trial
This is an interventional device feasibility trial for Coronary Artery Disease focused on measuring Coronary artery disease, iECG, MyoVista, Heart Test Labs, Wavelet analysis, Surface electrocardiogram
Eligibility Criteria
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
Sites / Locations
- Icahn School of Medicine at Mount Sinai
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Coronary artery disease
Arm Description
Patients scheduled for computed tomographic coronary angiography (CTA)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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)
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.
Serum electrolytes
Serum electrolytes level to include sodium, potassium, calcium, and magnesium
Serum creatinin level
Serum Brain natriuretic peptide (BNP) level
Serum cardiac enzymes
Serum cardiac enzymes include creatinin kinase MB fraction (CK-MB)
Serum high sensitivity C-reactive protein (hsCRP)
Full Information
NCT ID
NCT02560168
First Posted
September 23, 2015
Last Updated
October 19, 2017
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
Heart Test Laboratories, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02560168
Brief Title
Analysis of Surface EKG Signals to Identify Myocardial Dysfunction in Patients at Risk for Coronary Artery Disease
Official Title
Multidimensional Wavelet Analysis of Surface Electrocardiogram for Identifying Subclinical Myocardial Dysfunction in Patients at Risk for Coronary Artery Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
Heart Test Laboratories, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The MyoVista device is capable of detecting surface electrocardiogram signals and sensitive in detecting coronary artery disease compared to traditional computed tomography angiography (CTA)
Electrophysiological signals at the cellular level of myocardium are related to specific patterns on the MyoVista device
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary artery disease, iECG, MyoVista, Heart Test Labs, Wavelet analysis, Surface electrocardiogram
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Coronary artery disease
Arm Type
Experimental
Arm Description
Patients scheduled for computed tomographic coronary angiography (CTA)
Intervention Type
Device
Intervention Name(s)
MyoVista device
Other Intervention Name(s)
iECG
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Computed tomographic coronary angiography
Other Intervention Name(s)
CTA
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
Transthoracic Echocardiography
Other Intervention Name(s)
Echocardiogram
Primary Outcome Measure Information:
Title
Colorized waveform
Description
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.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Change in coronary plaque burden
Description
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)
Time Frame
Baseline and 3 months
Title
Myocardial wall motion score index (WMSI)
Description
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.
Time Frame
Baseline
Title
Serum electrolytes
Description
Serum electrolytes level to include sodium, potassium, calcium, and magnesium
Time Frame
3 months
Title
Serum creatinin level
Time Frame
3 months
Title
Serum Brain natriuretic peptide (BNP) level
Time Frame
3 months
Title
Serum cardiac enzymes
Description
Serum cardiac enzymes include creatinin kinase MB fraction (CK-MB)
Time Frame
3 months
Title
Serum high sensitivity C-reactive protein (hsCRP)
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Partho P Sengupta, MD, DM, FACC, FASE
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
12. IPD Sharing Statement
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Analysis of Surface EKG Signals to Identify Myocardial Dysfunction in Patients at Risk for Coronary Artery Disease
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