Clinical trial NCT02560168: 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
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Coronary artery disease
iECG
MyoVista
Heart Test Labs
Wavelet analysis
Surface electrocardiogram
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Heart Test Laboratories, Inc.
First posted: 2015-09-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

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

Primary outcomes:
measure: Colorized waveform
timeFrame: Day 1
Secondary outcomes:
measure: Change in coronary plaque burden
timeFrame: Baseline and 3 months
measure: Myocardial wall motion score index (WMSI)
timeFrame: Baseline
measure: Serum electrolytes
timeFrame: 3 months
measure: Serum creatinin level
timeFrame: 3 months
measure: Serum Brain natriuretic peptide (BNP) level
timeFrame: 3 months
measure: Serum cardiac enzymes
timeFrame: 3 months
measure: Serum high sensitivity C-reactive protein (hsCRP)
timeFrame: 3 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Partho P Sengupta, MD, DM, FACC, FASE
role: PRINCIPAL_INVESTIGATOR
References: