Status:
WITHDRAWN
Evaluation of Serial Troponin and Cardiac Multimarkers at the Point of Care in the Emergency Department
Lead Sponsor:
Abbott RDx Cardiometabolic
Conditions:
Acute Myocardial Infarction
Chest Pain
Eligibility:
All Genders
18+ years
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 w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00907231
Start Date
February 1 2010
End Date
May 1 2010
Last Update
July 21 2015
Active Locations (6)
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1
Loyola University Medical Center
Maywood, Illinois, United States, 60153
2
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
3
Oregon Health and Sciences University
Portland, Oregon, United States, 97239
4
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212