Phase 3
N=1,101
Evaluation of a New Cardiac Biomarker Assay
Acute Coronary Syndrome · Acute Myocardial Infarction
Bottom Line
View on ClinicalTrials.gov: NCT01608100 ↗Enrolled (actual)
1,101
Serious AEs
0.0%
Results posted
Mar 2015
Primary outcome: Primary: Clinical Performance - Area Under the Curve — 0.9326; 0.9197; 0.9412; 0.9431 Probability
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ARCHITECT STAT High Sensitive Troponin I Assay (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Diagnostics Division
- Primary completion
- Aug 2014
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 |
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.
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.
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.