Evaluation of a New Cardiac Biomarker Assay

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2014-09-30

Brief Summary

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The objective of the study is to evaluate the performance and intended use of a new cardiac biomarker test, Troponin I, in an intended use population. Blood specimens will be tested using the new investigational test that detects the level of Troponin I. Results will be compared to the diagnosis of whether or not an acute myocardial infarction (MI) occurred.

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Detailed Description

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The purpose of the cardiac biomarker Troponin I is to aid in the diagnosis of myocardial infarction.The assay is also intended to assist in the prognosis relative risk to all cause mortality (ACM) and major adverse cardiac events (MACE) consisting of myocardial infarction, revascularization, and cardiac death in patients who present with symptoms suggestive of acute coronary syndrome (ACS) without a diagnosis of myocardial infarction.

All specimens were collected under a separate specimen collection protocol (Protocol No, 7B5-02-09A01-01: Clinical Specimen Procurement for Biomarker Evaluation of Suspected ACS). The specimens that will be tested include approximately 8300 specimens collected from 1101 subjects presenting to Emergency Departments with signs and symptoms of Acute Coronary Syndrome and will be provided to the clinical sites performing investigational Troponin I testing.

Conditions

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Acute Coronary Syndrome Acute Myocardial Infarction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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ARCHITECT STAT High Sensitive Troponin I Assay testing

All subjects will have their blood tested by the investigational ARCHITECT STAT High SensitiveTroponin I assay.

Group Type EXPERIMENTAL

ARCHITECT STAT High Sensitive Troponin I Assay

Intervention Type DEVICE

Test blood samples from the ARCHITECT STAT High Sensitive Troponin I Assay. Results obtained will be used to assess the prognosis of subjects for risk of ACM/MACE in the timeframes (30 days and 90 days) after the Emergency Department visit.

Troponin results will be compared to documented ACM/MACE events at the 30 day and 90 day time points after Emergency Department visit.

Interventions

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ARCHITECT STAT High Sensitive Troponin I Assay

Test blood samples from the ARCHITECT STAT High Sensitive Troponin I Assay. Results obtained will be used to assess the prognosis of subjects for risk of ACM/MACE in the timeframes (30 days and 90 days) after the Emergency Department visit.

Troponin results will be compared to documented ACM/MACE events at the 30 day and 90 day time points after Emergency Department visit.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* presenting to the Emergency Department with symptoms consistent with or suggestive of Acute Coronary Syndrome (ACS) defined as at least 5 minutes of chest pain (or symptoms consistent with myocardial ischemia) up to 6 hours prior to initial evaluation.
* an Electrocardiogram (ECG) result within 2 hours of presentation for observation of Acute Coronary Syndrome (ACS).
* greater than 18 years of age.
* not known to be pregnant.
* agreement to the follow-up required by the study.

Exclusion Criteria

* prior participation in this study.
* require dialysis for end stage renal disease.
* history of a previous heart transplant.
* coexisting disorder associated with limited life expectancy.
* currently participating in another investigational device or drug study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No