Evaluation of a New Cardiac Biomarker Assay

Completed · Phase 3

Conditions studied: Acute Coronary Syndrome, Acute Myocardial Infarction

In brief

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.

Key facts

Study ID

NCT01608100

Run by

Abbott Diagnostics Division

People needed

1101

Starts

2012-06-01

Expected to finish

2014-09-01

Last updated by the study team

2015-03-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• presenting to the Emergency Department with symptoms consistent with or suggestive of Acute Coronary Syndrome (ACS) defined as at least 5 minutes of chest pain (or symptoms consistent with myocardial ischemia) up to 6 hours prior to initial evaluation.
• an Electrocardiogram (ECG) result within 2 hours of presentation for observation of Acute Coronary Syndrome (ACS).
• greater than 18 years of age.
• not known to be pregnant.
• agreement to the follow-up required by the study.

You may not qualify if…

• prior participation in this study.
• require dialysis for end stage renal disease.
• history of a previous heart transplant.
• coexisting disorder associated with limited life expectancy.
• currently participating in another investigational device or drug study.

Where it is running

• Chandler Regional Medical Center — Chandler, Arizona, United States
• Stanford University School of Emergency Medicine — Palo Alto, California, United States
• Nationwide Laboratory Services — Fort Lauderdale, Florida, United States
• John T Mather Memorial Hospital — Port Jefferson, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Pennsylvania State University- Hershey Medical Center — Hershey, Pennsylvania, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Hospital Physicians in Clinical Research — Austin, Texas, United States
• Hospital Physicians in Clinical Research — Bryan, Texas, United States
• Dept of Emergency Medicine University of Virginia — Charlottesville, Virginia, United States
• St Joseph Hospital — Bellingham, Washington, United States

Full record on ClinicalTrials.gov

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