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NCT02699788 Clinical Trial

Emergency Department MCG for Suspected Acute Coronary Syndrome

Acute Coronary Syndrome Clinical Trial

Official title:
Emergency Department MCG for Suspected Acute Coronary Syndrome

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02699788
Other study ID # TGH0006
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date April 2016
Est. completion date November 29, 2017

Study information
Verified date September 2019
Source Tampa General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date November 29, 2017
Est. primary completion date November 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• Multifunction Cardiogram

Locations
Country Name City State
United States Tampa General Hospital Tampa Florida

Sponsors (1)
Lead Sponsor Collaborator
Tampa General Hospital

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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