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

NCT01562730 | Unknown

• 1 other identifier: HTL-01-11
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

No previous cardiovascular disease

Individuals without any history of cardiovascular disease

Previous cardiovascular disease

Individuals with history of cardiovascular disease

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consecutive individuals undergoing a clinically indicated Computed Tomography Coronary Angiography

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cardiocentro Ticino: lead
• Meditrial SrL: collaborator

Study Sites (1)

Fondazione Cardiocentro Ticino

Lugano, CH-6900, Switzerland

RECRUITING

Related Publications (3)

• 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.

  PMID: 19406736 BACKGROUND

• 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.

  PMID: 18573865 BACKGROUND

• 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.

  PMID: 3203132 BACKGROUND

Related Links

• Fondazione Cardiocentro Ticino
• Heart Test Laboratories Inc.

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Angelo Auricchio, MD PhD FESC

  Fondazione Cardiocentro Ticino

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angelo Auricchio, MD PhD FESC

CONTACT

+41 91 805 3340; Angelo.Auricchio@cardiocentro.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 22, 2012
• First Posted: March 26, 2012
• Study Start: April 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: May 1, 2012

Record last verified: 2012-04

Locations

CH (1)