Emergency Department MCG for Suspected Acute Coronary Syndrome

Not Applicable

Withdrawn

• Conditions: Acute Coronary Syndrome
• Interventions: Device: Multifunction Cardiogram

• Registration Number: NCT02699788
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-01
• Study First Submitted QC: 2016-03-02
• Study First Posted: 2016-03-04
• Study Start: 2016-04
• Primary Completion: 2017-11
• Study Completion: 2017-11-29
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-09
• Last Update Posted: 2019-09-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Multifunction Cardiogram	Multifunction Cardiogram	non-invasive computerized, multiphase, resting electrocardiogram analysis device

Primary Outcome Measures

Name	Time	Method
Accuracy of MCG as assessed by the development of major adverse cardiac events (MACE).	30 days	MACE will be defined as the composite of cardiac death, myocardial infarction (MI), or coronary revascularization.; 2.2 Seco11dary

Trial Locations

Locations (1)

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States