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| Name | Class |
|---|---|
| Canadian VIGOUR Centre | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 - no pre-hospital biomarkers | No Intervention | Standard of Care | |
| Group 2 - pre-hospital biomarkers | Experimental | Troponin and BNP measured on a POC meter in the ambulance on the way to the hospital. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alere Triage Meter Pro | Device | Troponin and BNP measured on point of care meter. |
|
| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Explore the incremental value pre-hospital BNP on primary and secondary endpoints. | Assessed up to 30 months |
Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Paul Armstrong, MD | Canadian VIGOUR Centre | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grey Nuns Community Hospital | Edmonton | Alberta | Canada | |||
| Misericordia Community Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28261896 | Derived | Sepehrvand N, Zheng Y, Armstrong PW, Welsh RC, Ezekowitz JA. Identifying Low-risk Patients for Early Discharge From Emergency Department Without Using Subjective Descriptions of Chest Pain: Insights From Providing Rapid Out of Hospital Acute Cardiovascular Treatment (PROACT) 3 and 4 Trials. Acad Emerg Med. 2017 Jun;24(6):691-700. doi: 10.1111/acem.13183. Epub 2017 May 12. | |
| 26627881 |
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| ID | Term |
|---|---|
| D000072658 | Non-ST Elevated Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 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 |
| Edmonton |
| Alberta |
| Canada |
| Northeast Community Health Centre (NECHC) | Edmonton | Alberta | Canada |
| Royal Alexandra Hospital | Edmonton | Alberta | Canada |
| University of Alberta Hospital | Edmonton | Alberta | Canada |
| Derived |
| Ezekowitz JA, Welsh RC, Weiss D, Chan M, Keeble W, Khadour F, Sharma S, Tymchak W, Sookram S, Brass N, Knapp D, Koshy TL, Zheng Y, Armstrong PW. Providing Rapid Out of Hospital Acute Cardiovascular Treatment 4 (PROACT-4). J Am Heart Assoc. 2015 Dec 1;4(12):e002859. doi: 10.1161/JAHA.115.002859. |
| 26289822 | Derived | Sepehrvand N, Zheng Y, Armstrong PW, Welsh R, Goodman SG, Tymchak W, Khadour F, Chan M, Weiss D, Ezekowitz JA. Alignment of site versus adjudication committee-based diagnosis with patient outcomes: Insights from the Providing Rapid Out of Hospital Acute Cardiovascular Treatment 3 trial. Clin Trials. 2016 Apr;13(2):140-8. doi: 10.1177/1740774515601437. Epub 2015 Aug 19. |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |