Coronary Artery DiseaseNCT01562730
Myovista iECG for Detecting Ischemic Heart Disease: Comparison With Computed Tomography Coronary Angiography
An observational study of Coronary Artery Disease, run by Cardiocentro Ticino at 1 site in Switzerland.
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 Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 1,000 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2012to Apr 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Consecutive individuals undergoing a clinically indicated Computed Tomography Coronary Angiography
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Fondazione Cardiocentro Ticino
Lugano, CH-6900
Angelo Auricchio, MD PhD FESC, +41 91 805 3340, Angelo.Auricchio@cardiocentro.org
Angelo Auricchio, MD PhD FESC
About this study
Official title: Incremental Value of Signal Processed Surface Electrocardiography (IECG) for Detecting Ischemic Heart Disease: Comparison With Computed Tomography Coronary Angiography (CTCA)
Study evaluates the new technique MyoVista™ iECG sensitivity and ability to predict myocardial diseases, comparing iECG results with Computed Tomography Coronary Angiography findings
Read the 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
- 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);
- 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);
- whether MyoVista™ iECG abnormality is a better predictor of traditional risk factors to prevalence of CAP in individuals without history of cardiovascular disease.
- 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
- Medical subject headings
- Coronary Artery Disease, Myocardial Ischemia, Coronary Disease, Heart Diseases, Cardiovascular Diseases, Arteriosclerosis, Arterial Occlusive Diseases, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| No previous cardiovascular disease | Individuals without any history of cardiovascular disease | |
| Previous cardiovascular disease | Individuals with history of cardiovascular disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionApr 2013 (estimated)
- Study completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardiocentro Ticino
- Sponsor type
- University, hospital or other
- Collaborators
- Meditrial SrL
- Responsible party
- Principal investigator, Angelo Auricchio, Cardiocentro Ticino
- Investigators
- Angelo Auricchio, MD PhD FESC, Principal investigator, Fondazione Cardiocentro Ticino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01562730
- Sponsor's protocol ID
- HTL-01-11
- Status last verified
- Apr 2012
- First submitted
- 22 Mar 2012
- Last updated
- 1 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19406736Henneman 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.
PubMed 18573865DeLong 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.
PubMed 3203132
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incremental Value of Signal Processed Surface Electrocardiography (IECG) for Detecting Ischemic Heart Disease: Comparison With Computed Tomography Coronary Angiography (CTCA)
- ClinicalTrials.gov ID
- NCT01562730
- Acronym / sponsor ID
- HTL-01-11
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Disease, Myocardial Ischemia, Coronary Disease, Heart Diseases, Cardiovascular Diseases, Arteriosclerosis, Arterial Occlusive Diseases, Vascular Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Cardiocentro TicinoUniversity, hospital or other
- Collaborators
- Meditrial SrL
- Study start
- Apr 2012
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 26 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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);
- 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);
- whether MyoVista™ iECG abnormality is a better predictor of traditional risk factors to prevalence of CAP in individuals without history of cardiovascular disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No previous cardiovascular disease | – | –Individuals without any history of cardiovascular disease |
| Previous cardiovascular disease | – | –Individuals with history of cardiovascular disease |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive individuals undergoing a clinically indicated Computed Tomography Coronary Angiography
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison between Myovista iECG findings and CTCA (gold standard) results
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2012.
- Background: PubMed 19406736Faletra 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.
- Background: PubMed 18573865Henneman 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.
- Background: PubMed 3203132DeLong 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.
- Fondazione Cardiocentro TicinoLink provided by the sponsor.
- Heart Test Laboratories Inc.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angelo Auricchio, MD PhD FESC principal investigator
Fondazione Cardiocentro Ticino
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Cardiocentro Ticino at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Angelo Auricchio, MD PhD FESC (+41 91 805 3340, Angelo.Auricchio@cardiocentro.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison between Myovista iECG findings and CTCA (gold standard) results (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01562730, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2012.