Back to resultsEmergency Department MCG for Suspected Acute Coronary Syndrome
Primary Purpose
Acute Coronary Syndrome
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Multifunction Cardiogram
Sponsored by
About this trial
This is an interventional diagnostic trial for Acute Coronary Syndrome
Eligibility Criteria
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.
Sites / Locations
- Tampa General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Multifunction Cardiogram
Arm Description
non-invasive computerized, multiphase, resting electrocardiogram analysis device
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT02699788
First Posted
February 1, 2016
Last Updated
September 9, 2019
Sponsor
Tampa General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02699788
Brief Title
Emergency Department MCG for Suspected Acute Coronary Syndrome
Official Title
Emergency Department MCG for Suspected Acute Coronary Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Withdrawn
Why Stopped
No patients enrolled, sponsor refused to pay site invoices.
Study Start Date
April 2016 (Actual)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 29, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tampa General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Multifunction Cardiogram
Arm Type
Experimental
Arm Description
non-invasive computerized, multiphase, resting electrocardiogram analysis device
Intervention Type
Device
Intervention Name(s)
Multifunction Cardiogram
Primary Outcome Measure Information:
Title
Accuracy of MCG as assessed by the development of major adverse cardiac events (MACE).
Description
MACE will be defined as the composite of cardiac death, myocardial infarction (MI), or coronary revascularization.
2.2 Seco11dary
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Wilson, MD
Organizational Affiliation
Tampa General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Emergency Department MCG for Suspected Acute Coronary Syndrome
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