Analysis of Surface EKG Signals to Identify Myocardial Dysfunction in Patients at Risk for Coronary Artery Disease
NCT ID: NCT02560168
Last Updated: 2017-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
200 participants
INTERVENTIONAL
2015-10-31
2016-06-30
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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Coronary artery disease
Patients scheduled for computed tomographic coronary angiography (CTA)
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age\>18 years
* Both genders
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Heart Test Laboratories, Inc.
INDUSTRY
Icahn School of Medicine at Mount Sinai
OTHER
Responsible Party
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Partho Sengupta
Associate Professor of Medicine and Director of Cardiac Ultrasound Research and Core Lab
Principal Investigators
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Partho P Sengupta, MD, DM, FACC, FASE
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Locations
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Icahn School of Medicine at Mount Sinai
New York, New York, United States
Countries
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Other Identifiers
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Heart Test Laboratories, Inc.
Identifier Type: OTHER
Identifier Source: secondary_id
GCO 15-0726
Identifier Type: -
Identifier Source: org_study_id