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

Abbott RDx Cardiometabolic

Status: Withdrawn

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

Study type: Observational

Funder types: Other

Identifiers

NCT00907231

BSTE-0112

Details and patient eligibility

About

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).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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