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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02620397

Enrollment

1500

Registered

2015-12-03

Start date

2015-03-31

Completion date

2016-11-30

Last updated

2015-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome

Brief summary

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

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.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

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 -

Design outcomes

Primary

Measure	Time frame	Description
Clinical performance of the Meritas Troponin I test	24-hours	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)

Secondary

Measure	Time frame	Description
Prognostic capability of sponsor's Meritas Troponin I to predict mortality (all-cause death) and cardiac events (i.e., MI, cardiac death).	1 year	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

Countries

United States

Outcome results