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Emergency Department MCG for Suspected Acute Coronary Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02699788
Recruitment Status : Withdrawn (No patients enrolled, sponsor refused to pay site invoices.)
First Posted : March 4, 2016
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
Tampa General Hospital

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.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Device: Multifunction Cardiogram Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Emergency Department MCG for Suspected Acute Coronary Syndrome
Actual Study Start Date : April 2016
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 29, 2017

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



Primary Outcome Measures :
  1. 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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02699788


Locations
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United States, Florida
Tampa General Hospital
Tampa, Florida, United States, 33606
Sponsors and Collaborators
Tampa General Hospital
Investigators
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Principal Investigator: Jason Wilson, MD Tampa General Hospital
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Responsible Party: Tampa General Hospital
ClinicalTrials.gov Identifier: NCT02699788    
Other Study ID Numbers: TGH0006
First Posted: March 4, 2016    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Syndrome
Emergencies
Disease
Pathologic Processes
Disease Attributes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases