Evaluation of Serial Troponin and Cardiac Multimarkers at the Point of Care in the Emergency Department

Abbott RDx Cardiometabolic6 sites in 1 countryFebruary 2010

ConditionsAcute Myocardial Infarction Chest Pain Acute Coronary Syndrome

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Acute Myocardial Infarction
Sponsor: Abbott RDx Cardiometabolic
Locations: 6
Status: Withdrawn
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a multi-center study to assess the diagnostic accuracy of the Troponin I assay in the Biosite Triage Cardio3 Panel at the point-of-care (POC) in adults presenting to the emergency department with possible acute myocardial infarction (AMI).

Registry

clinicaltrials.gov

Start Date

February 2010

End Date

May 2010

Last Updated

10 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Abbott RDx Cardiometabolic

Eligibility Criteria

Inclusion Criteria

•18 years of age or older at time of enrollment
•Presenting to the ED within 6 hours from onset of chest discomfort (pain, pressure, tightness, etc) consistent with a possible diagnosis of AMI or ACS and with an initial ECG non-diagnostic for injury (or injury equivalent resulting in emergent reperfusion therapy). (NOTE: Subjects who have chest discomfort that is episodic or stuttering in nature may be included if the ED presentation is within 6 hours of symptom onset.)
•Experiencing at least 30 minutes of chest pain or other anginal equivalent symptoms. (Note: Subjects who have symptoms of shorter duration due to pharmacologic intervention may be included.)

Exclusion Criteria

•Patient (or Legal Representative) unable or unwilling to provide written informed consent.
•Patient unwilling or unlikely to comply with study procedures, including protocol-specified blood sampling or telephone follow-up at 30 days and 6 months.
•Vulnerable populations as deemed inappropriate for study by site principal investigator.
•ST-elevation or other ECG criteria that result that is diagnostic for AMI and results in patient being sent for percutaneous coronary interventions (PCI) or being treated with thrombolytics
•Pulmonary Edema requiring CPAP, BIPAP, or mechanical ventilation
•Tachyarrhythmias (SVT, V-Tach, rapid atrial fib)
•End Stage Renal Disease on Hemodialysis
•Cardiac Arrest prior to arrival
•Implantable Defibrillator firing prior to arrival
•Hemodynamically unstable patients