Emergency Department MCG for Suspected Acute Coronary Syndrome

September 9, 2019 updated by: Tampa General Hospital
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33606
        • Tampa General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Multifunction Cardiogram
non-invasive computerized, multiphase, resting electrocardiogram analysis device
Device: Multifunction Cardiogram

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of MCG as assessed by the development of major adverse cardiac events (MACE).
Time Frame: 30 days

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

2.2 Seco11dary
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tampa General Hospital

Investigators

  • Principal Investigator: Jason Wilson, MD, Tampa General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

November 29, 2017

Study Registration Dates

First Submitted

February 1, 2016

First Submitted That Met QC Criteria

March 2, 2016

First Posted (Estimate)

March 4, 2016

Study Record Updates

Last Update Posted (Actual)

September 11, 2019

Last Update Submitted That Met QC Criteria

September 9, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TGH0006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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