NCT02699788

Brief Summary

The goal of this study is to assess a new non-invasive computerized, multiphase, resting electrocardiogram analysis device in early identification of patients at risk for acute coronary syndrome. The overall objective is to assess the association between the results from a resting MCG and 30-day cardiovascular outcome in patients presenting to the emergency department with suspected coronary disease.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
withdrawn

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

February 1, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 4, 2016

Completed
28 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2017

Completed
Last Updated

September 11, 2019

Status Verified

September 1, 2019

Enrollment Period

1.6 years

First QC Date

February 1, 2016

Last Update Submit

September 9, 2019

Conditions

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

  • Accuracy of MCG as assessed by the development of major adverse cardiac events (MACE).

    MACE will be defined as the composite of cardiac death, myocardial infarction (MI), or coronary revascularization. 2.2 Seco11dary

    30 days

Study Arms (1)

Multifunction Cardiogram

EXPERIMENTAL

non-invasive computerized, multiphase, resting electrocardiogram analysis device

Device: Multifunction Cardiogram

Interventions

Multifunction CardiogramDEVICE
Multifunction Cardiogram

Eligibility Criteria

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

You may qualify if:

  • Age 18 and over.
  • Symptoms consistent with a possible acute coronary syndrome per the treating emergency physician.
  • Has an electrocardiogram performed while in the ED.

You may not qualify if:

  • Acute ST-segment elevation MI.
  • Patient unable or unwilling to complete follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Jason Wilson, MD

    Tampa General Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2016

First Posted

March 4, 2016

Study Start

April 1, 2016

Primary Completion

November 1, 2017

Study Completion

November 29, 2017

Last Updated

September 11, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)