Clinical trial NCT01562730: Myovista iECG for Detecting Ischemic Heart Disease: Comparison With Computed Tomography Coronary Angiography
Official title: Incremental Value of Signal Processed Surface Electrocardiography (IECG) for Detecting Ischemic Heart Disease: Comparison With Computed Tomography Coronary Angiography (CTCA)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Keywords: Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
iECG
12 leads ECG
Lead sponsor: Cardiocentro Ticino
Sponsor class: OTHER
Collaborators: name: Meditrial SrL
First posted: 2012-03-26
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive individuals undergoing a clinically indicated Computed Tomography Coronary Angiography

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Comparison between Myovista iECG findings and CTCA (gold standard) results
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Lugano
country: Switzerland
facility: Fondazione Cardiocentro Ticino
Study officials:
affiliation: Fondazione Cardiocentro Ticino
name: Angelo Auricchio, MD PhD FESC
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.