Providing Rapid Out of Hospital Acute Cardiovascular Treatment (PROACT)

This study is currently recruiting participants.
Verified July 2012 by University of Alberta
Sponsor:
Collaborator:
Canadian VIGOUR Centre
Information provided by (Responsible Party):
Robert Welsh, University of Alberta
ClinicalTrials.gov Identifier:
NCT01634425
First received: October 3, 2011
Last updated: July 2, 2012
Last verified: July 2012
  Purpose

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) and acute heart failure (AHF) .


Condition Intervention Phase
NSTEMI
Acute Heart Failure
Device: Alere Triage Meter Pro
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Providing Rapid Out of Hospital Acute Cardiovascular Treatment (PROACT) NSTEMI and AHF Biomarkers Study

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Time from first medical contact to administration of appropriate evidence based therapy. [ Time Frame: From date of first medical contact until first appropriate therapy given, assessed up to 30 months ] [ Designated as safety issue: No ]
    First medical contact is defined as arrival of the paramedics on scene. First appropriate therapy for NSTEMI is defined as: receiving oral antiplatelet agent (excluding ASA) or intravenous/subcutaneous antithrombotic agents. First appropriate therapy for AHF is defined as: IV nitroglycerin, or oral or intravenous furosemide. Final disposition for other diagnoses is a diagnosis, institution of therapy for other diagnosis or admission/discharge for that diagnosis.


Secondary Outcome Measures:
  • Time from first medical contact to clinical diagnosis [ Time Frame: From time of first medical contact to clinical diagnosis, assessed up to 30 months ] [ Designated as safety issue: No ]
  • Time from first medical contact to hospital admission or discharge from emergency - all patients [ Time Frame: From time of first medical contact up to hospital admission or discharge, whichever comes first, assessed up to 30 months ] [ Designated as safety issue: No ]
  • Length of hospital stay [ Time Frame: From date of first medical contact until hospital discharge, assessed up to 30 months ] [ Designated as safety issue: No ]
  • In-hospital clinical events - death, shock, HF, re-MI [ Time Frame: From date of first medical contact until hospital discharge, assessed up to 30 months ] [ Designated as safety issue: No ]
  • 30-day and 1 year mortality [ Time Frame: From date of first medical contact until 1 year or death, whichever comes first, assessed up to 30 months ] [ Designated as safety issue: No ]
  • 30 day hospitalization or re-hospitalization [ Time Frame: From date of first medical contact until 30 days, assessed up to 30 months ] [ Designated as safety issue: No ]
  • Cost analysis of implementing pre-hospital point of care analysis [ Time Frame: From date of first medical contact until 1 year, assessed up to 30 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 1800
Study Start Date: November 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Point of Care Meter

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 or AHF through utilization of systematic clinical assessment, pre-hospital 12 lead electrocardiogram and point of care measurement of biomarkers. We hypothesize that establishing a pre-hospital diagnosis in these conditions 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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient activates pre-hospital EMS for symptoms of acute chest discomfort or dyspnea for which acute coronary disease or heart failure is deemed to be the most probable diagnosis.
  2. Patient is older than 18
  3. Patients able to give informed consent

Exclusion Criteria:

  1. Patient with documented ST elevation on the initial 12 lead ECG
  2. Patients with a prior diagnosis that is compatible with recurrent symptoms of dyspnea or chest discomfort i.e. severe asthma, etc.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01634425

Contacts
Contact: Robert C Welsh, MD 780-407-3613 robert.welsh@albertahealthservices.ca

Locations
Canada, Alberta
University of Alberta Hospital Recruiting
Edmonton, Alberta, Canada
Contact: Robert C Welsh, MD     780-407-3613     robert.welsh@albertahealthservices.ca    
Royal Alexandra Hospital Recruiting
Edmonton, Alberta, Canada
Contact: Rob Welsh, MD     780-407-3613     robert.welsh@albertahealthservices.ca    
Misericordia Community Hospital Recruiting
Edmonton, Alberta, Canada
Contact: Rob Welsh, MD     780-407-3613     robert.welsh@albertahealthservices.ca    
Northeast Community Health Centre (NECHC) Recruiting
Edmonton, Alberta, Canada
Contact: Rob Welsh, MD     780-407-3613     robert.welsh@albertahealthservices.ca    
Grey Nuns Community Hospital Recruiting
Edmonton, Alberta, Canada
Contact: Rob Welsh, MD     780-407-3613     robert.welsh@albertahealthservices.ca    
Sponsors and Collaborators
University of Alberta
Canadian VIGOUR Centre
Investigators
Study Chair: Paul Armstrong, MD Canadian VIGOUR Centre
  More Information

No publications provided

Responsible Party: Robert Welsh, Principal Investigator, University of Alberta
ClinicalTrials.gov Identifier: NCT01634425     History of Changes
Other Study ID Numbers: PROACT NSTEMI & AHF
Study First Received: October 3, 2011
Last Updated: July 2, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Alberta:
NSTEMI
Acute Heart Failure
Point of Care Biomarkers

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013