Diagnosis and Treatment of ACS in the ED: The Impact of Rapid Bedside cTnI Testing on Outcomes
Recruitment status was Active, not recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
In a randomized, controlled clinical trial, point-of care testing at the bedside using the cardiac biomarker troponin I in ED patients with possible ACS will be compared to traditional testing of this assay for myocardial necrosis obtained in the central laboratory. Our hypothesis: point-of-care testing for troponin I will decrease the time for disposition of patients with possible ACS in the emergency setting and decrease the time required for administering appropriate therapies for these patients.
| Study Type: | Observational |
| Study Design: | Additional Descriptors: Convenience Sample Observational Model: Natural History Time Perspective: Longitudinal Time Perspective: Prospective |
| Official Title: | Diagnosis and Treatment of Acute Coronary Syndromes in the Emergency Department: The Impact of Rapid Bedside cTnI Testing on Outcomes |
| Estimated Enrollment: | 2000 |
| Study Start Date: | December 2004 |
| Estimated Study Completion Date: | December 2006 |
Cardiac troponin I is routinely used in the emergency department as a risk stratification tool for detecting myocardial necrosis in patients with possible acute coronary syndrome. It is our hypothesis that having bedside, point-of-care testing for TnI in the ED will decrease time needed to disposition patients to home from the ED or send to the cardiac catheterization laboratory or intensive care setting. Similarly, having point-of-care testing in the ED should decrease the time required to deliver anti-platelet drugs such as aspirin and glycoprotein IIb/IIIa inhibitors and anti-thrombin agents such as heparin to high risk patients found to have a positive TnI test. This will be evaluated in a randomized, controlled clinical trial of 2000 patients. Half will have the test performed in the ED at the bedside (point-of-care) while the other half will receive the usual lab results obtained from the central lab (typically requiring 1.5-2 hours to return).
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age greater than or equal to 21 years old
- Chest pain or other symptoms that lead to drawing cardiac bio-markers for possible ACS diagnosis
Exclusion Criteria:
- Presentation with chest pain in the presence of a tachydysrhythmia (ventricular tachycardia, supraventricular tachycardia, or rapid atrial fibrillation)
- Presentation with ECG diagnostic for STEMI
Contacts and Locations| United States, California | |
| Stanford University | |
| Stanford, California, United States, 94305-6203 | |
| United States, Michigan | |
| William Beaumont Hospital | |
| Royal Oak, Michigan, United States, 48073 | |
| United States, Ohio | |
| The Jewish Hospital | |
| Cincinnati, Ohio, United States, 45236 | |
| United States, Pennsylvania | |
| The University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104-6205 | |
| Study Chair: | Walter B Gibler, MD | EMCREG International; University Emergency Physicians, Inc; University of Cincinnati College of Medicine |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00222352 History of Changes |
| Other Study ID Numbers: | TJH 0428 |
| Study First Received: | September 14, 2005 |
| Last Updated: | February 27, 2007 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University Emergency Physicians:
|
Unstable Angina Non-ST-segment Myocardial Infarction Myocardial Necrosis Troponin I |
Additional relevant MeSH terms:
|
Angina, Unstable Acute Coronary Syndrome Angina Pectoris Myocardial Ischemia Heart Diseases |
Cardiovascular Diseases Vascular Diseases Chest Pain Pain Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013