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

This study has been terminated.
(Business Decision)
Sponsor:
Information provided by:
Biosite
ClinicalTrials.gov Identifier:
NCT00907231
First received: May 20, 2009
Last updated: May 3, 2010
Last verified: May 2010

May 20, 2009
May 3, 2010
February 2010
April 2010   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00907231 on ClinicalTrials.gov Archive Site
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Evaluation of Serial Troponin and Cardiac Multimarkers at the Point of Care in the Emergency Department
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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).

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Approximately 400 adults presenting to the ED with possible AMI will be enrolled.

  • Acute Myocardial Infarction
  • Chest Pain
  • Acute Coronary Syndrome
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
400
May 2010
April 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00907231
BSTE-0112
No
Director of Clinical Operations, Biosite, Inc
Biosite
Not Provided
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Biosite
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP