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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
  Purpose

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
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:

Estimated Enrollment: 400
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)
  Eligibility

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.

Criteria

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

Locations
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
Biosite
  More Information

No publications provided

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: May 3, 2010
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 17, 2014