NCT01608100

Evaluation of a New Cardiac Biomarker Assay

Design Validation Protocol for the Evaluation of ARCHITECT STAT High Sensitive Troponin I Assay

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,101 (actual)
• Sponsor: Abbott Diagnostics Division · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The purpose of the cardiac biomarker Troponin I is to aid in the diagnosis of myocardial infarction.The assay is also intended to assist in the prognosis relative risk to all cause mortality (ACM) and major adverse cardiac events (MACE) consisting of myocardial infarction, revascularization, and cardiac death in patients who present with symptoms suggestive of acute coronary syndrome (ACS) without a diagnosis of myocardial infarction. All specimens were collected under a separate specimen collection protocol (Protocol No, 7B5-02-09A01-01: Clinical Specimen Procurement for Biomarker Evaluation of Suspected ACS). The specimens that will be tested include approximately 8300 specimens collected from 1101 subjects presenting to Emergency Departments with signs and symptoms of Acute Coronary Syndrome and will be provided to the clinical sites performing investigational Troponin I testing.

Conditions

• Acute Coronary Syndrome
• Acute Myocardial Infarction

Interventions

Type	Name	Description
DEVICE	ARCHITECT STAT High Sensitive Troponin I Assay	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.

Timeline

• Start date: 2012-06-01
• Primary completion: 2014-08-01
• Completion: 2014-09-01
• First posted: 2012-05-30
• Last updated: 2015-03-17
• Results posted: 2015-03-17

Locations

12 sites across 1 country: United States