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Completed

NCT Number: NCT02560168

Analysis of Surface EKG Signals to Identify 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

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MyoVista device

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

Computed tomographic coronary angiography

Device

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

Transthoracic echocardiography

Device

Other names: Echocardiogram

Primary outcomes

  1. Colorized waveform

    Time frame: 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 outcomes

  1. Change in coronary plaque burden

    Time frame: 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)

  2. Myocardial wall motion score index (WMSI)

    Time frame: 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.

  3. Serum electrolytes

    Time frame: 3 months

    Serum electrolytes level to include sodium, potassium, calcium, and magnesium

  4. Serum creatinin level

    Time frame: 3 months

  5. Serum Brain natriuretic peptide (BNP) level

    Time frame: 3 months

  6. Serum cardiac enzymes

    Time frame: 3 months

    Serum cardiac enzymes include creatinin kinase MB fraction (CK-MB)

  7. Serum high sensitivity C-reactive protein (hsCRP)

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • Heart Test Laboratories, Inc.

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 25, 2015
Registry last updated
Oct 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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