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| Name | Class |
|---|---|
| Abbott | INDUSTRY |
| Jewish Hospital, Cincinnati, Ohio | OTHER |
| University of Pennsylvania | OTHER |
| Stanford University |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| central laboratory cTnI test | Control Group | ||
| Point of Care cTnL testing | Experimental Group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Point of Care cTnL testing | Diagnostic Test | The study design will be a phase IV prospective, randomized (1:1), parallel-group trial utilizing concurrent controls. The experimental group of interest will be patients receiving the POC cTnI test, and the control group will be patients receiving the central laboratory cTnI test. The treating physician will be blinded to the randomization and will receive only the POC results from half the study patients and only the laboratory results for the remaining half. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to disposition from the ED | The primary hypotheses are that i) POC testing using the i-STAT system reduces the time to disposition and discharge for low-risk patients being discharged directly from the ED, and ii) POC testing using the i-STAT system reduces the time to therapy compared to laboratory testing for the subset of patients requiring anti-thrombotic therapies such as heparin/LMW heparin or anti-platelet agents such as GPIIb/IIIa inhibitors or clopidogrel or PCI. These groups of patients (those with new ST-depression, recurrent pain, positive troponin, diabetes, age >65 years, or failed ASA and those discharged without a diagnosis associated with ischemic chest pain) will be extracted from the entire sample. The time from blood draw to initiation of therapy or to disposition and discharge will be computed and compared between the group with POC testing and the group with laboratory testing. | The time from blood draw to initiation of therapy or to disposition |
| Measure | Description | Time Frame |
|---|---|---|
| Time to departure | time of discharge to home or to the time of transfer to an inpatient setting |
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Inclusion criteria
Exclusion criteria
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Patients aged 21 years or older, presenting with symptoms suggestive of acute coronary syndromes, and having cardiac biomarker tests ordered by the treating emergency physician were enrolled. Patients with a tachydysrhythmia (ventricular tachycardia, supraventricular tachycardia, or rapid atrial fibrillation) or a 12-lead ECG diagnostic for acute myocardial infarction were excluded. Patients were enrolled at 4 sites across the United States between December 2004 and November 2006, with final data collection and verification occurring by March 2007.
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| Name | Affiliation | Role |
|---|---|---|
| Walter B Gibler, MD | University of Cincinnati | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305-6203 | United States | ||
| William Beaumont Hospital |
Blood samples banked for future use. Must be IRB approved before use.
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| ID | Term |
|---|---|
| D000789 | Angina, Unstable |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| OTHER |
| Mayo Clinic | OTHER |
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SERUM BANKING Each patient consented and enrolled will have whole blood and plasma saved and frozen. The amount of blood drawn for the study is 5 ml (per draw), which is to be placed in a lithium heparinzed tube. One ml of whole blood will be alloquoted, frozen at -70ºC, and shipped to the Study Coordinating Center. The remainder of the sample will be centrifuged, alloquoted, frozen at -70ºC, and shipped to the Study Coordinating Center. These blood samples will be de-identified and assigned a study ID #. There will be no genetic testing of these samples.
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| Royal Oak |
| Michigan |
| 48073 |
| United States |
| The Jewish Hospital | Cincinnati | Ohio | 45236 | United States |
| The University of Pennsylvania | Philadelphia | Pennsylvania | 19104-6205 | United States |
| D014652 |
| Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D009336 | Necrosis |