Coronary Artery DiseaseNCT02560168
Analysis of Surface EKG Signals to Identify Myocardial Dysfunction in Patients at Risk for Coronary Artery Disease
A study testing MyoVista device, Computed tomographic coronary angiography and Transthoracic Echocardiography in people with Coronary Artery Disease, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
1. The MyoVista device is capable of detecting surface electrocardiogram signals and sensitive in detecting coronary artery disease compared to traditional computed tomography angiography (CTA) 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- MyoVista device, Computed tomographic coronary angiography and Transthoracic Echocardiography
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Jun 2016
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sinus rhythms
- Age>18 years
- Both genders
Who cannot join
- Acute coronary syndromes(ACS)
- Contraindications to the administration of iodinated contrast
- Pregnancy
- Coronary artery bypass surgery (CABG)
- History of cardiac valvular replacement
- Implanted cardiac pacemaker
Show all 9Show fewer
- Chest deformities
- Unwilling or unable to provide informed consent for study participation
- Enrolled in another clinical study
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Multidimensional Wavelet Analysis of Surface Electrocardiogram for Identifying Subclinical Myocardial Dysfunction in Patients at Risk for Coronary Artery Disease
- The MyoVista device is capable of detecting surface electrocardiogram signals and sensitive in detecting coronary artery disease compared to traditional computed tomography angiography (CTA)
- Electrophysiological signals at the cellular level of myocardium are related to specific patterns on the MyoVista device
- Changes in MyoVista device output and can indicative of future CAD outcomes and need for revascularization
Read the detailed description
Background Myocardial ischemia is caused by myocardial oxygen supply and demand mismatch. Despite that coronary artery disease (CAD) is the major cause of myocardial ischemia, the symptoms may occur even in the absence of significant CAD. One of the mechanisms suggested for myocardial ischemia in these patients is microvascular ischemia (i.e. mismatch in microscopic vessels), affecting the myocardium (i.e. heart muscle) at the cellular level.
A novel electrocardiographic recording method, the iECG is capable of capturing and amplifying signals from the cellular level that are much lower biologic signals than those processed by a traditional electrocardiogram (ECG). These recordings focus on early detection of myocardial abnormalities by non-linear analysis of electrical activity and physiological phenomenon. This novel assessment might be capable of detecting subclinical myocardial dysfunction in a variety of heart diseases.
Specific Aims
Aim#1: Study the feasibility of detection of CAD using iECG compared to computed tomographic coronary angiography (CTA).
Aim#2: Study the association between patterns of iECG and myocardial dysfunction in patients without CAD compared to echocardiography.
Aim#3: Study the effect of changes in iECG output on future outcomes of CAD and need for revascularization.
- Conditions
- Coronary Artery Disease
- Being tested
- MyoVista device, Computed tomographic coronary angiography, Transthoracic Echocardiography
- Keywords
- Coronary artery disease, iECG, MyoVista, Heart Test Labs, Wavelet analysis, Surface electrocardiogram
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyoVista deviceDevice
Also called iECG
MyoVista device is a standard EKG device with additional capabilities in detecting cellular level myocardial electrophysiological signals. The device involves placing leads on the chest, similar to a traditional EKG device
Computed tomographic coronary angiographyDevice
Also called CTA
Traditional method of detecting coronary artery disease. CTA will be performed using 64-detector row or higher scanners with electrocardiographic gating in accordance with the Society of Cardiovascular Computed Tomography (SCCT) guidelines. Approximately 80 to 100 ml of intravenous contrast, followed by 50 to 80 ml of saline, will be administered at a rate of 5 ml/s via a power injector through an antecubital vein (on forearm near the elbow).
Transthoracic EchocardiographyDevice
Also called Echocardiogram
| Study group | Role | What they receive |
|---|---|---|
| Coronary artery disease | Experimental | Patients scheduled for computed tomographic coronary angiography (CTA) Receives: Device: MyoVista device; Device: Computed tomographic coronary angiography; Device: Transthoracic Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colorized waveform
Spectrum analysis to represent levels and locations of cellular energy and automates the analysis into a simple indication of the level of myocardial abnormality if present.
Measured: Day 1
Secondary outcomes (7)
Change in coronary plaque burden
Change in coronary plaque burden at 3 months compared to baseline. Coronary plaque burden will be assessed by assigning a score (0 to 5) according to the SCCT guidelines (0, Normal: absence of plaque and no luminal stenosis; 1, Minimal: plaque with <25% stenosis; 2, Mild: 25% to 49% stenosis; 3, Moderate: 50%to 69% stenosis; 4, Severe: 70% to 99% stenosis; 5, Complete occlusion)
Measured: Baseline and 3 months
Myocardial wall motion score index (WMSI)
Myocardial wall motion score index (WMSI) will be obtained by dividing the left ventricle into 16 segments7. Each of the segments will be assigned a score that is based on myocardial thickening (1 for Normal or hyperkinetic, 2 for hypokinetic, 3 for akinetic, 4 for dyskinesis, 5 for aneurysmal dilatation). WMSI will be calculated as the sum of scores divided by the number of segments visualized.
Measured: Baseline
Serum electrolytes
Serum electrolytes level to include sodium, potassium, calcium, and magnesium
Measured: 3 months
Serum creatinin level
Measured: 3 months
Serum Brain natriuretic peptide (BNP) level
Measured: 3 months
Serum cardiac enzymes
Serum cardiac enzymes include creatinin kinase MB fraction (CK-MB)
Measured: 3 months
Serum high sensitivity C-reactive protein (hsCRP)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Heart Test Laboratories, Inc.
- Responsible party
- Principal investigator, Partho Sengupta, Icahn School of Medicine at Mount Sinai
- Investigators
- Partho P Sengupta, MD, DM, FACC, FASE, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02560168
- Sponsor's protocol ID
- GCO 15-0726
- Other IDs
- Heart Test Laboratories, Inc.
- Status last verified
- Oct 2017
- First submitted
- 23 Sep 2015
- Last updated
- 23 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidimensional Wavelet Analysis of Surface Electrocardiogram for Identifying Subclinical Myocardial Dysfunction in Patients at Risk for Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT02560168
- Acronym / sponsor ID
- GCO 15-0726
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease, iECG, MyoVista, Heart Test Labs, Wavelet analysis, Surface electrocardiogram
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Heart Test Laboratories, Inc.
- Study start
- Oct 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 25 Sep 2015 (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.
- The MyoVista device is capable of detecting surface electrocardiogram signals and sensitive in detecting coronary artery disease compared to traditional computed tomography angiography (CTA)
- Electrophysiological signals at the cellular level of myocardium are related to specific patterns on the MyoVista device
- Changes in MyoVista device output and can indicative of future CAD outcomes and need for revascularization
Detailed description
Background Myocardial ischemia is caused by myocardial oxygen supply and demand mismatch. Despite that coronary artery disease (CAD) is the major cause of myocardial ischemia, the symptoms may occur even in the absence of significant CAD. One of the mechanisms suggested for myocardial ischemia in these patients is microvascular ischemia (i.e. mismatch in microscopic vessels), affecting the myocardium (i.e. heart muscle) at the cellular level.
A novel electrocardiographic recording method, the iECG is capable of capturing and amplifying signals from the cellular level that are much lower biologic signals than those processed by a traditional electrocardiogram (ECG). These recordings focus on early detection of myocardial abnormalities by non-linear analysis of electrical activity and physiological phenomenon. This novel assessment might be capable of detecting subclinical myocardial dysfunction in a variety of heart diseases.
Specific Aims
Aim#1: Study the feasibility of detection of CAD using iECG compared to computed tomographic coronary angiography (CTA).
Aim#2: Study the association between patterns of iECG and myocardial dysfunction in patients without CAD compared to echocardiography.
Aim#3: Study the effect of changes in iECG output on future outcomes of CAD and need for revascularization.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coronary artery disease | Experimental | Device: MyoVista device, Device: Computed tomographic coronary angiography, Device: Transthoracic EchocardiographyPatients scheduled for computed tomographic coronary angiography (CTA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Sinus rhythms
- Age>18 years
- Both genders
Key exclusion criteria (9 listed)
- Acute coronary syndromes(ACS)
- Contraindications to the administration of iodinated contrast
- Pregnancy
- Coronary artery bypass surgery (CABG)
- History of cardiac valvular replacement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MyoVista deviceAlso: iECGMyoVista device is a standard EKG device with additional capabilities in detecting cellular level myocardial electrophysiological signals. The device involves placing leads on the chest, similar to a traditional EKG device | Device | Coronary artery disease |
| Computed tomographic coronary angiographyAlso: CTATraditional method of detecting coronary artery disease. CTA will be performed using 64-detector row or higher scanners with electrocardiographic gating in accordance with the Society of Cardiovascular Computed Tomography (SCCT) guidelines. Approximately 80 to 100 ml of intravenous contrast, followed by 50 to 80 ml of saline, will be administered at a rate of 5 ml/s via a power injector through an antecubital vein (on forearm near the elbow). | Device | Coronary artery disease |
| Transthoracic EchocardiographyAlso: Echocardiogram | Device | Coronary artery disease |
Primary outcome
Colorized waveform
Time frame: Day 1
Spectrum analysis to represent levels and locations of cellular energy and automates the analysis into a simple indication of the level of myocardial abnormality if present.
7 secondary outcomes
Change in coronary plaque burden
Time frame: Baseline and 3 months
Myocardial wall motion score index (WMSI)
Time frame: Baseline
Serum electrolytes
Time frame: 3 months
Serum creatinin level
Time frame: 3 months
Serum Brain natriuretic peptide (BNP) level
Time frame: 3 months
Serum cardiac enzymes
Time frame: 3 months
Serum high sensitivity C-reactive protein (hsCRP)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2017.
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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.
Partho P Sengupta, MD, DM, FACC, FASE principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyoVista device, Computed tomographic coronary angiography and Transthoracic Echocardiography in people with Coronary Artery Disease, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
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 3 inclusion and 9 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: finished, as of the sponsor's last update on 23 Oct 2017. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Colorized waveform (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Oct 2017.