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

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).

Study Overview

• Status: Withdrawn
• Conditions: Chest Pain; Acute Coronary Syndrome; Acute Myocardial Infarction

• Study Type: Observational

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Biosite

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Anticipated): April 1, 2010
• Study Completion (Anticipated): May 1, 2010

Study Registration Dates

• First Submitted: May 20, 2009
• First Submitted That Met QC Criteria: May 21, 2009
• First Posted (Estimate): May 22, 2009

Study Record Updates

• Last Update Posted (Estimate): July 21, 2015
• Last Update Submitted That Met QC Criteria: July 20, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Myocardial Infarction; Infarction; Chest Pain; Acute Coronary Syndrome
• Other Study ID Numbers: BSTE-0112