Emergency Department MCG for Suspected Acute Coronary Syn... | NCT02699788

Studies
Emergency Department MCG for Suspected Acute Coronary Syndrome

NCT02699788

Sponsor

Tampa General Hospital

Status

Withdrawn

Last Update Posted

Sep 11, 2019Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Acute Coronary Syndrome

Interventions

Multifunction Cardiogram

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No patients enrolled, sponsor refused to pay site invoices.

Expanded Access Info

Start Date

Apr 2016Actual

Primary Completion Date

Nov 2017Actual

Completion Date

Nov 29, 2017Actual

First Submitted Date

Feb 1, 2016

First Submission Date that Met QC Criteria

Mar 2, 2016

First Posted Date

Mar 4, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 9, 2019

Last Update Posted Date

Sep 11, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Multifunction Cardiogram	Experimental	non-invasive computerized, multiphase, resting electrocardiogram analysis device	Device: Multifunction Cardiogram

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Multifunction Cardiogram	Device		Multifunction Cardiogram

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jason Wilson, MD	Tampa General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tampa General Hospital		Tampa	Florida	33606	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D054058	Acute Coronary Syndrome

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided