A Study of Elecsys® Troponin T hs Gen 6 in Participants With Symptoms of Acute Coronary Syndrome

Hoffmann-La Roche5,429 enrolled

Overview

This prospective, non-interventional, single arm, longitudinal cohort multicenter study will recruit approximately 5600 consecutive all-comers, consisting of patients with signs and symptoms of acute coronary syndromes (ACS) who present in the emergency department (ED). The main objective of the study is to determine the clinical performance of Elecsys Troponin T hs Gen 6 versus the centrally adjudicated clinical diagnosis at various time points after ED presentation using the previously determined clinical cut-off of a universal 99th percentile upper reference limit.

Study Type

OBSERVATIONAL

Enrollment

5,429

Conditions

Acute Coronary Syndrome Myocardial Infarction

Interventions

Elecsys® Troponin T hs Gen 6DIAGNOSTIC_TEST

It is an immunoassay for the in vitro quantitative determination of cardiac troponin T (cTnT) in human serum and plasma using cobas e platforms. This investigational immunoassay is intended to aid in the diagnosis of myocardial infarction.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥20 years * Signed Informed Consent Form * Troponin or other cardiac marker determination planned as part of suspected acute coronary syndromes routine care * Demonstrating symptoms suggestive of acute coronary syndrome and/or myocardial ischemia, such as any of the following: 1. Chest pain, pressure, or a burning sensation across the precordium and epigastrium; 2. Pain that radiates to neck, shoulder, jaw, back, upper abdomen, or either arm; 3. Acute onset or worsening dyspnea; 4. Nausea, vomiting or indigestion; 5. Lightheadedness or syncope; 6. Diaphoresis; 7. Generalized weakness or fatigue; OR, asymptomatic subjects or patients with atypical symptoms in whom myocardial infarction is being suspected. Exclusion Criteria: * None

Locations (50)

El Centro Regional Medical Center

El Centro, California, United States

UCSD La Jolla ED

La Jolla, California, United States

University of Florida

Gainesville, Florida, United States

Tampa General Hospital

Tampa, Florida, United States

Parkview Research

Fort Wayne, Indiana, United States

Outcomes

Primary Outcomes

Sensitivity of Elecsys® Troponin T hs Gen 6 Against the Centrally Adjudicated Clinical Diagnosis at Timepoint T3aid

The sensitivity of a diagnostic test is the percentage of true positive (TP) tests out of all patients with a condition. It is calculated as follows: (TP)/(TP + false negatives (FN))\*100%.

Time frame: T3aid (121 to 240 minutes) after participant presentation at the emergency department

Secondary Outcomes

Sensitivity of Elecsys® Troponin T hs Gen 6 Against the Centrally Adjudicated Clinical Diagnosis at Specified Timepoints

The sensitivity of a diagnostic test is the percentage of true positive tests out of all patients with a condition. It is calculated as follows: (TP)/(TP + FN)\*100%.

Time frame: T0aid (0 to 60 minutes), T1aid (61 to 120 minutes), T5aid (241 to 360 minutes), and T6+aid (>360 minutes) after participant presentation at the emergency department

Specificity of Elecsys® Troponin T hs Gen 6 Against the Centrally Adjudicated Clinical Diagnosis at Specified Timepoints

The specificity of a diagnostic test is the percentage of true negative (TN) tests out of all patients who do not have a condition. It is calculated as follows: (TN)/(TN + false positives (FP))\*100%.

Time frame: T0aid (0 to 60 minutes), T1aid (61 to 120 minutes), T3aid (121 to 240 minutes), T5aid (241 to 360 minutes), and T6+aid (>360 minutes) after participant presentation at the emergency department

Negative Predictive Value of Elecsys® Troponin T hs Gen 6 Against the Centrally Adjudicated Clinical Diagnosis at Specified Timepoints

The negative predictive value of a diagnostic test is the percentage of true negative tests out of all of the negative findings. It is calculated as follows: (TN)/(TN + FN)\*100%.

Positive Predictive Value of Elecsys® Troponin T hs Gen 6 Against the Centrally Adjudicated Clinical Diagnosis at Specified Timepoints

The positive predictive value of a diagnostic test is the percentage of true positive tests out of all of the positive findings. It is calculated as follows: (TP)/(TP + FP)\*100%.

Negative Predictive Value of Fast Rule-Out of Myocardial Infarction Using Elecsys® Troponin T hs Gen 6 and the European Society of Cardiology 0/1-Hour Algorithm

The negative predictive value of a diagnostic test is the percentage of true negative tests out of all of the negative findings. It is calculated as follows: (TN)/(TN + FN)\*100%.

Time frame: T0fast (0 to 60 minutes) after participant presentation at the emergency department and T1fast (30 to 90 minutes from T0fast sample)