Providing Rapid Out of Hospital Acute Cardiovascular Treatment (PROACT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 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: September 24, 2013
Last verified: September 2013
  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).


Condition Intervention Phase
NSTEMI
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) Novel Proximal Pathways for Non ST Elevation Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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:
  • Time to administration of appropriate evidence based therapy [ Time Frame: Assessed up to 30 months. ] [ Designated as safety issue: No ]
    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 [ Time Frame: Assessed up to 30 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 30-day all-cause mortality [ Time Frame: Assessed up to 30 months ] [ Designated as safety issue: No ]
  • 30 day all-cause hospitalization or re-hospitalization [ Time Frame: Assessed up to 30 months ] [ Designated as safety issue: No ]
  • 30-day composite (all-cause mortality or all-cause hospitalization) [ Time Frame: Assessed up to 30 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Explore the incremental value pre-hospital BNP on primary and secondary endpoints. [ Time Frame: Assessed up to 30 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 1100
Study Start Date: November 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: December 2014 (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 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.

  Eligibility

Ages Eligible for Study:   31 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Study First Received: October 3, 2011
Last Updated: September 24, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Alberta:
NSTEMI
Point of Care Biomarkers

ClinicalTrials.gov processed this record on October 19, 2014