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

Withdrawn

• Conditions: Acute Coronary Syndrome; Acute Myocardial Infarction; Chest Pain

• Registration Number: NCT00907231
• Lead Sponsor: Abbott RDx Cardiometabolic

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-05-20
• Study First Submitted QC: 2009-05-21
• Study First Posted: 2009-05-22
• Study Start: 2010-02
• Primary Completion: 2010-04
• Study Completion: 2010-05
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-20
• Last Update Posted: 2015-07-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 thrombolytics6.
• 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
• Trauma injury to the chest

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (6)

Loyola University Medical Center; 🇺🇸 Maywood, Illinois, United States

Stony Brook University Medical Center; 🇺🇸 Stony Brook, New York, United States

Oregon Health and Sciences University; 🇺🇸 Portland, Oregon, United States

Allegheny General Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States

Erlanger Medical Center; 🇺🇸 Chattanooga, Tennessee, United States

Mountain States Health Alliance; 🇺🇸 Johnson City, Tennessee, United States