CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,101 enrolled
Drug / intervention
ARCHITECT STAT High Sensitive Troponin I Assaydevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01608100
NCT01608100Phase 3Completed
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Design Validation Protocol for the Evaluation of ARCHITECT STAT High Sensitive Troponin I Assay

Abbott Diagnostics Division·interventional·Posted May 30, 2012·Updated Mar 17, 2015

In Brief

A Phase 3 clinical trial evaluating ARCHITECT STAT High Sensitive Troponin I Assay for Acute Coronary Syndrome and Acute Myocardial Infarction. Completed, enrolled 1,101 participants across 12 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Coronary Syndrome, Acute Myocardial Infarction
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMay 30, 2012
Enrollment StartJun 1, 2012
Primary CompletionAug 1, 2014
Study CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 14.1 years ago

Interventions

ARCHITECT STAT High Sensitive Troponin I Assaydevice

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.