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

Clinical Study to Validate the Use of a New Point of Care Troponin I Test as an Aid in the Diagnosis of Myocardial Infarction and Prognosis of Subjects Presenting With Symptoms of Acute Coronary Syndrome

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)

Study Overview

• Status: Unknown
• Conditions: Acute Coronary Syndrome

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 1500

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94110
      • San Francisco General Hospital & Trauma Center
  • Florida
    • Gainesville, Florida, United States, 32608
      • University of Florida
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Eastern Idaho Regional Medical Center
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville
    • Louisville, Kentucky, United States, 40202
      • Kentucky Clinical Trials Laboratories
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • Hennepin County Medical Ctr
  • Nevada
    • Las Vegas, Nevada, United States, 89109
      • Sunrise Hospital
  • North Carolina
    • Charlotte, North Carolina, United States, 28293
      • Carolinas Medical Center
    • Greenville, North Carolina, United States, 27834
      • East Carolina University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson Univeristy
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University
  • Texas
    • Houston, Texas, United States, 77030
      • Ben Taub

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Approximately 1000 to 1500 adult subjects presenting to emergency departments (ED) with symptoms suggestive of acute coronary sydrome (ACS) and/or myocardial ischemia

Description

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 -

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical performance of the Meritas Troponin I test	Clinical performance indicators (Sensitivity, Specificity, Positive Predictive Value (PPV) and Negative Predictive Value (NPV) and their respective 95 % confidence intervals (CIs) will be calculated for the quantitative determination of cardiac troponin I (cTnI) for use as an aid in the diagnosis of myocardial infarction (MI)	24-hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prognostic capability of sponsor's Meritas Troponin I to predict mortality (all-cause death) and cardiac events (i.e., MI, cardiac death).	Kaplan-Meier survival curves and risk ratios. A multivariate Cox proportional model with known risk factors as covariates in addition to the Troponin test result will be included in the data analysis	1 year

Collaborators and Investigators

• Sponsor: Trinity Biotech
• Investigators: Study Director: Jim Rock, Trinity Biotech

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): October 1, 2015
• Study Completion (Anticipated): November 1, 2016

Study Registration Dates

• First Submitted: November 27, 2015
• First Submitted That Met QC Criteria: November 30, 2015
• First Posted (Estimate): December 3, 2015

Study Record Updates

• Last Update Posted (Estimate): December 15, 2015
• Last Update Submitted That Met QC Criteria: December 14, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome
• Other Study ID Numbers: CP7001_5ACS