Evaluation of a New Cardiac Biomarker Assay
Public ClinicalTrials.gov record NCT01608100. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Design Validation Protocol for the Evaluation of ARCHITECT STAT High Sensitive Troponin I Assay
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT01608100
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,101 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 2012 (Type not available)
- Primary completion
- Aug 2014 (Actual)
- Completion
- Sep 2014 (Actual)
- Last update posted
- Mar 17, 2015
2012 – 2014
United States locations
- U.S. sites
- 12
- U.S. states
- 10
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Chandler Regional Medical Center | Chandler | Arizona | 85224 | — |
| Stanford University School of Emergency Medicine | Palo Alto | California | 94304 | — |
| Nationwide Laboratory Services | Fort Lauderdale | Florida | 33309 | — |
| John T Mather Memorial Hospital | Port Jefferson | New York | 11777 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| Pennsylvania State University- Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104-4283 | — |
| Hospital Physicians in Clinical Research | Austin | Texas | 78752 | — |
| Hospital Physicians in Clinical Research | Bryan | Texas | 77802 | — |
| Dept of Emergency Medicine University of Virginia | Charlottesville | Virginia | 22908-2877 | — |
| St Joseph Hospital | Bellingham | Washington | 98225 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01608100, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 17, 2015 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01608100 live on ClinicalTrials.gov.