Diagnosis and Treatment of ACS in the ED: The Impact of Rapid Bedside cTnI Testing on Outcomes

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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).

Official Title
-----------------
Diagnosis and Treatment of Acute Coronary Syndromes in the Emergency Department: The Impact of Rapid Bedside cTnI Testing on Outcomes

Conditions
-----------------
Angina, Unstable

Intervention / Treatment
-----------------
* Diagnostic Test: Point of Care cTnL testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Age >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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| central laboratory cTnI test<br>Control Group | |
| Point of Care cTnL testing<br>Experimental Group | Diagnostic Test: Point of Care cTnL testing<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to departure |  | time of discharge to home or to the time of transfer to an inpatient setting | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Unstable Angina, Non-ST-segment Myocardial Infarction, Myocardial Necrosis, Troponin I