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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Cardiocentro Ticino.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Meditrial SrL
Information provided by (Responsible Party):
Angelo Auricchio, Cardiocentro Ticino
ClinicalTrials.gov Identifier:
NCT01562730
First received: March 22, 2012
Last updated: April 30, 2012
Last verified: April 2012
  Purpose

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


Condition Phase
Coronary Artery Disease
Phase 2

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Incremental Value of Signal Processed Surface Electrocardiography (IECG) for Detecting Ischemic Heart Disease: Comparison With Computed Tomography Coronary Angiography (CTCA)

Resource links provided by NLM:


Further study details as provided by Cardiocentro Ticino:

Primary Outcome Measures:
  • Comparison between Myovista iECG findings and CTCA (gold standard) results [ Time Frame: one day ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 1000
Study Start Date: April 2012
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
No previous cardiovascular disease
Individuals without any history of cardiovascular disease
Previous cardiovascular disease
Individuals with history of cardiovascular disease

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Consecutive individuals undergoing a clinically indicated Computed Tomography Coronary Angiography

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01562730

Contacts
Contact: Angelo Auricchio, MD PhD FESC +41 91 805 3340 Angelo.Auricchio@cardiocentro.org

Locations
Switzerland
Fondazione Cardiocentro Ticino Recruiting
Lugano, Switzerland, CH-6900
Contact: Angelo Auricchio, MD PhD FESC    +41 91 805 3340    Angelo.Auricchio@cardiocentro.org   
Principal Investigator: Angelo Auricchio, MD PhD FESC         
Sub-Investigator: François Regoli, MD.         
Sub-Investigator: Marta Aceña, MD         
Sponsors and Collaborators
Cardiocentro Ticino
Meditrial SrL
Investigators
Principal Investigator: Angelo Auricchio, MD PhD FESC Fondazione Cardiocentro Ticino
  More Information

Additional Information:
Publications:
Responsible Party: Angelo Auricchio, Principal Investigator, Cardiocentro Ticino
ClinicalTrials.gov Identifier: NCT01562730     History of Changes
Other Study ID Numbers: HTL-01-11
Study First Received: March 22, 2012
Last Updated: April 30, 2012
Health Authority: Switzerland: Swissmedic

Keywords provided by Cardiocentro Ticino:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
iECG
12 leads ECG

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Heart Diseases
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 24, 2014