Multidimensional Wavelet Analysis of Surface Electrocardiogram for Identifying Subclinical Myocardial Dysfunction in Patients at Risk for Coronary Artery Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Colorized waveform
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Partho Sengupta
Associate Professor of Medicine and Director of Cardiac Ultrasound Research and Core Lab
Icahn School of Medicine at Mount Sinai
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
Outcomes
Primary Outcomes
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
- Change in coronary plaque burden(Baseline and 3 months)
- Myocardial wall motion score index (WMSI)(Baseline)
- Serum electrolytes(3 months)
- Serum cardiac enzymes(3 months)
- Serum creatinin level(3 months)
- Serum Brain natriuretic peptide (BNP) level(3 months)
- Serum high sensitivity C-reactive protein (hsCRP)(3 months)