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NCT01608100 · ClinicalTrials.gov registry record · Phase 3
Evaluation of a New Cardiac Biomarker Assay
A Phase 3 study, sponsored by Abbott Diagnostics Division.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,101
- Enrollment target
NCT01608100: Completed Phase 3 study, sponsored by Abbott Diagnostics Division.
NCT01608100 is a Phase 3 study that has completed, run by Abbott Diagnostics Division. The registered enrollment target is 1,101 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (43% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01608100, a Phase 3 study, has completed, sponsored by Abbott Diagnostics Division.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,101 participants
- Enrollment target
Study 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.
Primary Outcome
The ARCHITECT STAT High Sensitive Troponin-I assay clinical performance was evaluated by calculating the Area Under the Curve (AUC). The Area Under the Curve that was assessed, is used to determine the optimum clinical sensitivity and specificity for the ARCHITECT STAT High Sensitive Troponin-I assay. The ARCHITECT STAT High Sensitive Troponin-I assay results were generated from subject's specimens collected at three collection time points in three tube types (K2 EDTA, Lithium Heparin Separator
Interventions
- DEVICE ARCHITECT STAT High Sensitive Troponin I Assay
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,101 participants |
| Start Date | 2012-06 |
| Est. Completion | 2014-09 |
| Phase | Phase 3 |
What the finished NCT01608100 record still lists
NCT01608100 is an interventional study that assigns participants to a tested intervention. Its 1,101 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (43% higher).
The record links to 0 conditions, and to 1 intervention - of which ARCHITECT STAT High Sensitive Troponin I Assay is the first listed.
NCT01608100 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01608100 about?
NCT01608100 is a clinical study titled "Evaluation of a New Cardiac Biomarker Assay". 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 ...
What is the current status of trial NCT01608100?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,101 participants. The study started on 2012-06. Estimated completion is 2014-09.
What interventions are being tested in trial NCT01608100?
The interventions under investigation include: ARCHITECT STAT High Sensitive Troponin I Assay (DEVICE).
Who is sponsoring clinical trial NCT01608100?
This trial is sponsored by Abbott Diagnostics Division, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01608100's enrollment target sits among peer trials
1,101 252nd of 2000 higher than 1,749 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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