NCT02560168

Brief Summary

  1. 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. 2.Electrophysiological signals at the cellular level of myocardium are related to specific patterns on the MyoVista device
  3. 3.Changes in MyoVista device output and can indicative of future CAD outcomes and need for revascularization

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P50-P75 for not_applicable coronary-artery-disease

Timeline
Completed

Started Oct 2015

Shorter than P25 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 25, 2015

Completed
6 days until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

October 23, 2017

Status Verified

October 1, 2017

Enrollment Period

8 months

First QC Date

September 23, 2015

Last Update Submit

October 19, 2017

Conditions

Coronary Artery Disease

Keywords

Coronary artery diseaseiECGMyoVistaHeart Test LabsWavelet analysisSurface electrocardiogram

Outcome Measures

Primary Outcomes (1)

  • 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.

    Day 1

Secondary Outcomes (7)

  • Change in coronary plaque burden

    Baseline and 3 months

  • Myocardial wall motion score index (WMSI)

    Baseline

  • Serum electrolytes

    3 months

  • Serum creatinin level

    3 months

  • Serum Brain natriuretic peptide (BNP) level

    3 months

  • +2 more secondary outcomes

Study Arms (1)

Coronary artery disease

EXPERIMENTAL

Patients scheduled for computed tomographic coronary angiography (CTA)

Device: MyoVista deviceDevice: Computed tomographic coronary angiographyDevice: Transthoracic Echocardiography

Interventions

MyoVista deviceDEVICE

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

Also known as: iECG
Coronary artery disease
Computed tomographic coronary angiographyDEVICE

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).

Also known as: CTA
Coronary artery disease
Transthoracic EchocardiographyDEVICE
Also known as: Echocardiogram
Coronary artery disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sinus rhythms
  • Age\>18 years
  • Both genders

You may not qualify if:

  • 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
  • Chest deformities
  • Unwilling or unable to provide informed consent for study participation
  • Enrolled in another clinical study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Study Officials

  • Partho P Sengupta, MD, DM, FACC, FASE

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine and Director of Cardiac Ultrasound Research and Core Lab

Study Record Dates

First Submitted

September 23, 2015

First Posted

September 25, 2015

Study Start

October 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

October 23, 2017

Record last verified: 2017-10

Locations

US(1)