Myovista iECG for Detecting Ischemic Heart Disease: Comparison With Computed Tomography Coronary Angiography
- Conditions
- Coronary Artery Disease
- Registration Number
- NCT01562730
- Lead Sponsor
- Cardiocentro Ticino
- Brief Summary
Study evaluates the new technique MyoVista™ iECG sensitivity and ability to predict myocardial diseases, comparing iECG results with Computed Tomography Coronary Angiography findings
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1000
- chest pain,
- shortness of breath,
- syncope or equivocal stress testing including exercise ECG,
- myocardial perfusion imaging, or stress echocardiography unable to exclude significant coronary artery disease.
- All patients will provide written and oral consent to CTCA.
- Patient agrees to participate and signs the informed consent
- usually renal insufficiency (serum creatinine >120 mol/l),
- contraindications to the administration of iodinated contrast,
- pregnancy, acute coronary syndromes,
- and ventricular and/or supraventricular arrhythmias.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison between Myovista iECG findings and CTCA (gold standard) results one day Comparison of findings from the two methods will be made to demonstrate that Myovista iECG is equally effective as CTCA in predicting CAPs and/or CAD in individuals with or without history of cardiovascular disease, in terms of sensitivity, specificity and predictive value
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Fondazione Cardiocentro Ticino
🇨🇭Lugano, Switzerland