Study Stopped
Business Decision
Evaluation of Serial Troponin and Cardiac Multimarkers at the Point of Care in the Emergency Department
ESTIMATE
1 other identifier
observational
N/A
1 country
6
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Feb 2010
Shorter than P25 for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 20, 2009
CompletedFirst Posted
Study publicly available on registry
May 22, 2009
CompletedStudy Start
First participant enrolled
February 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedJuly 21, 2015
July 1, 2015
2 months
May 20, 2009
July 20, 2015
Conditions
Eligibility Criteria
Approximately 400 adults presenting to the ED with possible AMI will be enrolled.
You may qualify if:
- 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.)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Stony Brook University Medical Center
Stony Brook, New York, 11794, United States
Oregon Health and Sciences University
Portland, Oregon, 97239, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
Erlanger Medical Center
Chattanooga, Tennessee, 37403, United States
Mountain States Health Alliance
Johnson City, Tennessee, 37604, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 20, 2009
First Posted
May 22, 2009
Study Start
February 1, 2010
Primary Completion
April 1, 2010
Study Completion
May 1, 2010
Last Updated
July 21, 2015
Record last verified: 2015-07