Providing Rapid Out of Hospital Acute Cardiovascular Treatment (PROACT)

Study Overview
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Brief Summary
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The purpose of this study is to determine if early diagnosis and risk stratification acquired through pre-hospital clinical assessment, 12-lead electrocardiogram and point of care biomarkers will facilitate enhanced triage and treatment in patients with presumed non-ST elevation acute coronary syndromes (NSTEMI).

Detailed Description
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Utilizing the platform of pre-hospital STEMI research and clinical experience developed over the past decade; we now intend to investigate how best to achieve timely diagnosis and risk stratification of patients that present to pre-hospital emergency medical services with symptoms suspicious for acute NSTEMI through utilization of systematic clinical assessment, pre-hospital 12 lead electrocardiogram and point of care measurement of biomarkers. Additionally, where deemed appropriate these patients will be enrolled in a clinical Chest Pain Protocol utilizing the pre-hospital biomarkers. We hypothesize that establishing a pre-hospital diagnosis in this condition may facilitate efficient triage and -as appropriate- in-hospital disposition. Additionally, the enhanced pre-hospital assessment of this population will facilitate appropriate timely disposition of those patients not found to have acute cardiovascular disease. These processes will facilitate decanting the frequently overcrowded and under resources Emergency Departments.

Official Title
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Providing Rapid Out of Hospital Acute Cardiovascular Treatment (PROACT) Novel Proximal Pathways for Non ST Elevation Myocardial Infarction

Conditions
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NSTEMI

Intervention / Treatment
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* Device: Alere Triage Meter Pro


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Patient that activates pre-hospital Emergency Medical Services (EMS) for symptoms of acute chest discomfort for which acute cardiovascular disease is deemed to be the most probable diagnosis by EMS personnel. Patient is older than 30 years of age Patient is able to give informed consent Exclusion Criteria Patient with documented ST elevation on the initial 12 lead ECG Patient with a prior diagnosis that is compatible with another disease i.e. severe asthma, etc. Patient with Central Nervous System symptoms or syncope Patient with cardiac arrest, ventricular tachycardia or atrial fibrillation with heart rate > 110 bpm

Ages Eligible for Study
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Minimum Age: 31 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Group 1 - no pre-hospital biomarkers<br>Standard of Care | |
| Experimental: Group 2 - pre-hospital biomarkers<br>Troponin and BNP measured on a POC meter in the ambulance on the way to the hospital. | Device: Alere Triage Meter Pro<br>* Troponin and BNP measured on point of care meter.<br>* Other names: Point of Care Meter;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from first medical contact to final patient disposition. | An Adjudication Committee will examine the records to determine final diagnosis. Final patient disposition is defined as the time when a plan for patient discharge from the ED or admission to hospital is both established and documented. | From date of first medical contact until first appropriate therapy given, assessed up to 30 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to administration of appropriate evidence based therapy | From time of first medical contact to First appropriate therapy for NSTEMI is defined as: receiving oral antiplatelet agent (excluding ASA - which is routinely administered prior to diagnosis) or intravenous/subcutaneous antithrombotic agents (low molecular weight heparin or IV heparin or glycoprotein IIb/IIIa receptor inhibitors). | Assessed up to 30 months. | 
| Length of hospital stay for patients admitted to hospital |  | Assessed up to 30 months | 
| In-hospital clinical events (day 7 or discharge) all-cause mortality, cardiogenic shock, heart failure, re-Myocardial infarction |  | Assessed up to 30 months | 
| 30-day all-cause mortality |  | Assessed up to 30 months | 
| 30 day all-cause hospitalization or re-hospitalization |  | Assessed up to 30 months | 
| 30-day composite (all-cause mortality or all-cause hospitalization) |  | Assessed up to 30 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSTEMI, Point of Care Biomarkers