Providing Rapid Out of Hospital Acute Cardiovascular Treatment (PROACT) (PROACT)

October 19, 2015 updated by: Robert Welsh, University of Alberta

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

601

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
        • Royal Alexandra Hospital
      • Edmonton, Alberta, Canada
        • University of Alberta Hospital
      • Edmonton, Alberta, Canada
        • Grey Nuns Community Hospital
      • Edmonton, Alberta, Canada
        • Misericordia Community Hospital
      • Edmonton, Alberta, Canada
        • Northeast Community Health Centre (NECHC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

31 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  1. 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.
  2. Patient is older than 30 years of age
  3. Patient is able to give informed consent

Exclusion Criteria

  1. Patient with documented ST elevation on the initial 12 lead ECG
  2. Patient with a prior diagnosis that is compatible with another disease i.e. severe asthma, etc.
  3. Patient with Central Nervous System symptoms or syncope
  4. Patient with cardiac arrest, ventricular tachycardia or atrial fibrillation with heart rate > 110 bpm

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time from first medical contact to final patient disposition.
Time Frame: 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.
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
Time Frame: 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).
Assessed up to 30 months.
Length of hospital stay for patients admitted to hospital
Time Frame: Assessed up to 30 months
Assessed up to 30 months
In-hospital clinical events (day 7 or discharge) all-cause mortality, cardiogenic shock, heart failure, re-Myocardial infarction
Time Frame: Assessed up to 30 months
Assessed up to 30 months
30-day all-cause mortality
Time Frame: Assessed up to 30 months
Assessed up to 30 months
30 day all-cause hospitalization or re-hospitalization
Time Frame: Assessed up to 30 months
Assessed up to 30 months
30-day composite (all-cause mortality or all-cause hospitalization)
Time Frame: Assessed up to 30 months
Assessed up to 30 months

Other Outcome Measures

Outcome Measure
Time Frame
Explore the incremental value pre-hospital BNP on primary and secondary endpoints.
Time Frame: Assessed up to 30 months
Assessed up to 30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Collaborators

Canadian VIGOUR Centre

Investigators

  • Study Chair: Paul Armstrong, MD, Canadian VIGOUR Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

October 3, 2011

First Submitted That Met QC Criteria

July 2, 2012

First Posted (Estimate)

July 6, 2012

Study Record Updates

Last Update Posted (Estimate)

October 20, 2015

Last Update Submitted That Met QC Criteria

October 19, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROACT NSTEMI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on NSTEMI

Clinical Trials on Alere Triage Meter Pro

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovakia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe