Emergency Department MCG for Suspected Acute Coronary Syndrome

• Sponsor: Tampa General Hospital (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT02699788
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arm: 1
• Actual Duration (Months): 19.9
• Patients Per Site Per Month: 0

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome	Device: Multifunction Cardiogram	N/A

Study Design

• Study Type: Interventional
• 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: Apr 1, 2016
• Actual Primary Completion Date: Nov 1, 2017
• Actual Study Completion Date: Nov 29, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tampa General Hospital	Tampa	Florida	United States	33606

Sponsors and Collaborators

• Tampa General Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tampa General Hospital
• ClinicalTrials.gov Identifier: NCT02699788
• Other Study ID Numbers: TGH0006
• First Posted: Mar 4, 2016
• Last Update Posted: Sep 11, 2019
• Last Verified: Sep 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Acute Coronary Syndrome; Syndrome; Emergencies

Study Results

No Results Posted as of Sep 11, 2019