Trial record 1 of 4 for:
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This study has been withdrawn prior to enrollment.
Information provided by:
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
Acute Coronary Syndrome
||Observational Model: Cohort
Time Perspective: Prospective
| Study Start Date:
| Estimated Study Completion Date:
| 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:
|Accepts Healthy Volunteers:
Approximately 400 adults presenting to the ED with possible AMI will be enrolled.
- 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.)
- 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
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
|Loyola University Medical Center
|Maywood, Illinois, United States, 60153 |
|Stony Brook University Medical Center
|Stony Brook, New York, United States, 11794 |
|Oregon Health and Sciences University
|Portland, Oregon, United States, 97239 |
|Allegheny General Hospital
|Pittsburgh, Pennsylvania, United States, 15212 |
|Erlanger Medical Center
|Chattanooga, Tennessee, United States, 37403 |
|Mountain States Health Alliance
|Johnson City, Tennessee, United States, 37604 |
No publications provided
||Director of Clinical Operations, Biosite, Inc
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 20, 2009
||July 20, 2015
||United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 02, 2015
Acute Coronary Syndrome
Signs and Symptoms