Myovista iECG for Detecting Ischemic Heart Disease: Comparison With Computed Tomography Coronary Angiography

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01562730
• Other study ID #: HTL-01-11
• Status: Recruiting
• Phase: Phase 2
• First received: March 22, 2012
• Last updated: April 30, 2012
• Start date: April 2012
• Est. completion date: April 2013

Study information

• Verified date: April 2012
• Source: Cardiocentro Ticino
• Contact: Angelo Auricchio, MD PhD FESC
• Phone: +41 91 805 3340
• Email: Angelo.Auricchio[@]cardiocentro.org
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Observational

Clinical Trial Summary

Study evaluates the new technique MyoVista™ iECG sensitivity and ability to predict myocardial diseases, comparing iECG results with Computed Tomography Coronary Angiography findings

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 information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Myocardial Ischemia

Locations

Country	Name	City	State
Switzerland	Fondazione Cardiocentro Ticino	Lugano

Sponsors (2)

Lead Sponsor	Collaborator
Cardiocentro Ticino	Meditrial SrL

Country where clinical trial is conducted

Switzerland, 

References & Publications (3)

DeLong ER, DeLong DM, Clarke-Pearson DL. Comparing the areas under two or more correlated receiver operating characteristic curves: a nonparametric approach. Biometrics. 1988 Sep;44(3):837-45. — View Citation

Faletra FF, Klersy C, D'Angeli I, Penco M, Procaccini V, Pasotti E, Marcolongo A, Pedrazzini GB, De Castro S, Scappaticci M, Moccetti T, Auricchio A. Relation between coronary atherosclerotic plaques and traditional risk factors in people with no history of cardiovascular disease undergoing multi-detector computed coronary angiography. Heart. 2009 Aug;95(15):1265-72. doi: 10.1136/hrt.2009.167098. Epub 2009 Apr 29. — View Citation

Henneman MM, Schuijf JD, van Werkhoven JM, Pundziute G, van der Wall EE, Jukema JW, Bax JJ. Multi-slice computed tomography coronary angiography for ruling out suspected coronary artery disease: what is the prevalence of a normal study in a general clinical population? Eur Heart J. 2008 Aug;29(16):2006-13. doi: 10.1093/eurheartj/ehn284. Epub 2008 Jun 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison between Myovista iECG findings and CTCA (gold standard) results	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	one day	No

External Links

•   Fondazione Cardiocentro Ticino
•   Heart Test Laboratories Inc.
•   Meditrial Srl