Coronary Artery Disease Clinical Trial
Official title:
Incremental Value of Signal Processed Surface Electrocardiography (IECG) for Detecting Ischemic Heart Disease: Comparison With Computed Tomography Coronary Angiography (CTCA)
Study evaluates the new technique MyoVista™ iECG sensitivity and ability to predict myocardial diseases, comparing iECG results with Computed Tomography Coronary Angiography findings
Clinical need
Non-invasive identification of patients with coronary artery disease using a single, highly
reliable technique is challenging. Computed tomography coronary angiography (CTCA) has
emerged as a patient-friendly, accurate diagnostic tool. Compared to invasive coronary
angiography, the sensitivity and specificity of CTCA for detecting significant coronary
stenosis has been reported to be higher than 90%. Moreover, CTCA allows the detection of
nonobstructive coronary plaques (CAPs). However, the advantage of CTCA is frequently reduced
by significantly higher radiation exposure.
New MyoVista™ iECG technology
The MyoVista™ (Heart Test Laboratories Inc., Colleyville, TX, USA) is a novel
electrocardiographic device. The clinical set up of MyoVista™ is identical to that of a
traditional 12-lead ECG but it acquires and processes signal information in a way that
permits much greater resolution of the electrical activity associated with the myocardium
(iECG). This technology property of Heart Test Laboratories allows analysis of the entire
myocardium and provides visual indicators and waveforms for clinical evaluation.
Study rationale
MyoVista™ technology has been so far validated in cohorts of Asian patients undergoing a
clinically-indicated coronary angiography. These studies showed high positive and negative
predictive values for identification of CAD. In addition, preliminary studies performed in
the USA suggest a potential incremental value of iECG over routine surface ECG as a
screening tool for detection of subclinical LV dysfunction and latent cardiovascular risk.
The aim of this prospective controlled evaluation is to assess
1. the sensitivity, specificity, and predictive value of MyoVista™ iECG in consecutive
individuals without any history of cardiovascular disease undergoing a clinically
indicated Computed Tomography Coronary Angiography (CTCA) in detecting Coronary Artery
Plaque (CAP) and/or Coronary Artery Disease (CAD) (Group 1);
2. the sensitivity, specificity, and predictive value of MyoVista™ iECG in consecutive
individuals with history of cardiovascular disease undergoing a clinically indicated
CTCA in detecting the extent of CAP or CAD (Group 2);
3. whether MyoVista™ iECG abnormality is a better predictor of traditional risk factors to
prevalence of CAP in individuals without history of cardiovascular disease.
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Observational Model: Cohort, Time Perspective: Prospective
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