Providing Rapid Out of Hospital Acute Cardiovascular Treatment (PROACT)

Phase 4

Completed

• Conditions: NSTEMI
• Interventions: Device: Alere Triage Meter Pro

• Registration Number: NCT01634425
• Lead Sponsor: University of Alberta

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2011-10-03
• Study Start: 2011-11
• Study First Submitted QC: 2012-07-02
• Study First Posted: 2012-07-06
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-19
• Last Update Posted: 2015-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 601

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2 - pre-hospital biomarkers	Alere Triage Meter Pro	Troponin and BNP measured on a POC meter in the ambulance on the way to the hospital.

Primary Outcome Measures

Name	Time	Method
Time from first medical contact to final patient disposition.	From date of first medical contact until first appropriate therapy given, assessed up to 30 months	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.

Secondary Outcome Measures

Name	Time	Method
Time to administration of appropriate evidence based therapy	Assessed up to 30 months.	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).
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

Trial Locations

Locations (5)

Royal Alexandra Hospital; 🇨🇦 Edmonton, Alberta, Canada

Misericordia Community Hospital; 🇨🇦 Edmonton, Alberta, Canada

Grey Nuns Community Hospital; 🇨🇦 Edmonton, Alberta, Canada

Northeast Community Health Centre (NECHC); 🇨🇦 Edmonton, Alberta, Canada

University of Alberta Hospital; 🇨🇦 Edmonton, Alberta, Canada