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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00907231
Recruitment Status : Withdrawn (Business Decision)
First Posted : May 22, 2009
Last Update Posted : July 21, 2015
Information provided by:

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).

Condition or disease
Acute Myocardial Infarction Chest Pain Acute Coronary Syndrome

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : February 2010
Estimated Primary Completion Date : April 2010
Estimated Study Completion Date : May 2010

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Approximately 400 adults presenting to the ED with possible AMI will be enrolled.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00907231

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United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, New York
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
United States, Oregon
Oregon Health and Sciences University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
United States, Tennessee
Erlanger Medical Center
Chattanooga, Tennessee, United States, 37403
Mountain States Health Alliance
Johnson City, Tennessee, United States, 37604
Sponsors and Collaborators

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Responsible Party: Director of Clinical Operations, Biosite, Inc Identifier: NCT00907231     History of Changes
Other Study ID Numbers: BSTE-0112
First Posted: May 22, 2009    Key Record Dates
Last Update Posted: July 21, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
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Myocardial Infarction
Acute Coronary Syndrome
Chest Pain
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Neurologic Manifestations
Signs and Symptoms