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Clinical Study to Validate the Use of a New Point of Care Troponin I Test

NCT ID: NCT02620397

Last Updated: 2015-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-11-30

Brief Summary

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This trial is designed as a prospective, multi-center, observational study of "all-comers" eligible adult subjects presenting to participating emergency departments with symptoms suggestive of acute coronary syndrome (ACS)

Detailed Description

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This trial is designed as a prospective, multi-center, observational study of "all-comers" eligible adult subjects presenting to participating Emergency Departments (EDs) with symptoms suggestive of ACS and/or myocardial ischemia. Subjects presenting with symptoms suggestive of ACS will be screened and approached for consent for study enrollment by trained personnel.

After obtaining written informed consent, subjects will have up to 4 blood samples collected for cTnI testing using the Meritas Troponin I test and Meritas point-of-care (POC) Analyzer. Blood draws and testing will occur at 4 intervals over 24 hours.

Conditions

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Acute Coronary Syndrome

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. The informed consent must be signed by the subject, or the subject's legal authorized representative.
2. 21 years of age or greater at the time of enrollment
3. Subjects presenting to the ED with any symptoms suggestive of ACS and/or myocardial ischemia, such as but not limited to: subjects currently having chest pain, pressure or a burning sensation across the precordium and epigastrium, pain that radiates to neck, shoulder, jaw, back, upper abdomen and either arm.

Exclusion Criteria

1. Informed consent form not signed
2. Age \<21 years
3. Known pregnancy -
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Trinity Biotech

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jim Rock

Role: STUDY_DIRECTOR

Trinity Biotech

Locations

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San Francisco General Hospital & Trauma Center

San Francisco, California, United States

Site Status

University of Florida

Gainesville, Florida, United States

Site Status

Eastern Idaho Regional Medical Center

Idaho Falls, Idaho, United States

Site Status

Kentucky Clinical Trials Laboratories

Louisville, Kentucky, United States

Site Status

University of Louisville

Louisville, Kentucky, United States

Site Status

University of Maryland

Baltimore, Maryland, United States

Site Status

Hennepin County Medical Ctr

Minneapolis, Minnesota, United States

Site Status

Sunrise Hospital

Las Vegas, Nevada, United States

Site Status

Carolinas Medical Center

Charlotte, North Carolina, United States

Site Status

East Carolina University

Greenville, North Carolina, United States

Site Status

Thomas Jefferson Univeristy

Philadelphia, Pennsylvania, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Vanderbilt University

Nashville, Tennessee, United States

Site Status

Ben Taub

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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CP7001_5ACS

Identifier Type: -

Identifier Source: org_study_id