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

This study has been withdrawn prior to enrollment.
(Business Decision)
Information provided by:
ClinicalTrials.gov Identifier:
First received: May 20, 2009
Last updated: July 20, 2015
Last verified: July 2015
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).

Acute Myocardial Infarction
Chest Pain
Acute Coronary Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:

Further study details as provided by Biosite:

Enrollment: 0
Study Start Date: February 2010
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00907231

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
  More Information

Responsible Party: Director of Clinical Operations, Biosite, Inc
ClinicalTrials.gov Identifier: NCT00907231     History of Changes
Other Study ID Numbers: BSTE-0112 
Study First Received: May 20, 2009
Last Updated: July 20, 2015
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 23, 2016