Phase 3 Completed N=1,101 Diagnostic

Evaluation of a New Cardiac Biomarker Assay

Coronary Artery Disease · Myocardial Infarction

Source: ClinicalTrials.gov NCT01608100 ↗

Enrolled (actual)

1,101

Serious AEs

0.0%

Results posted

Mar 2015

Primary outcomePrimary: Clinical Performance - Area Under the Curve — 0.9326; 0.9197; 0.9412; 0.9431 Probability

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Clinical Performance - Area Under the Curve	0.9326; 0.9197; 0.9412; 0.9431; 0.9349; 0.9419	—
PRIMARY Clinical Performance- Sensitivity	84.44; 85.26; 87.32; 92.21; 91.86; 92.00	—
PRIMARY Clinical Performance- Specificity	85.73; 83.76; 86.35; 85.20; 83.72; 85.81	—
PRIMARY Clinical Performance- Negative Predictive Value (NPV)	98.10; 98.08; 98.73; 99.19; 99.05; 99.20	—
PRIMARY Clinical Performance- Positive Predictive Value (PPV)	38.78; 36.82; 35.84; 35.68; 35.75; 35.94	—
SECONDARY Prognosis	19; 30; 17; 30; 17; 29	0.0004 sig

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01608100). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.