MedTrace Logo

Evaluation of a New Cardiac Biomarker Assay

NCT01608100 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1101

Last updated 2015-03-17

Study results available
· View outcomes & findings →

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.

Conditions

  • Acute Coronary Syndrome
  • Acute Myocardial Infarction

Interventions

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.

Sponsors & Collaborators

  • Abbott Diagnostics Division

    lead INDUSTRY

Principal Investigators

  • Fred S Apple, PhD · Hennepin Healthcare Research Institute

  • Frank Peacock, MD

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2014-08-31
Completion
2014-09-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01608100 on ClinicalTrials.gov