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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01634425
Recruitment Status : Completed
First Posted : July 6, 2012
Last Update Posted : October 20, 2015
Canadian VIGOUR Centre
Information provided by (Responsible Party):
Robert Welsh, 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).

Condition or disease Intervention/treatment Phase
NSTEMI Device: Alere Triage Meter Pro Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 601 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : November 2011
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

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 Name: Point of Care Meter

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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).

  2. Length of hospital stay for patients admitted to hospital [ Time Frame: Assessed up to 30 months ]
  3. 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 ]
  4. 30-day all-cause mortality [ Time Frame: Assessed up to 30 months ]
  5. 30 day all-cause hospitalization or re-hospitalization [ Time Frame: Assessed up to 30 months ]
  6. 30-day composite (all-cause mortality or all-cause hospitalization) [ Time Frame: Assessed up to 30 months ]

Other Outcome Measures:
  1. Explore the incremental value pre-hospital BNP on primary and secondary endpoints. [ Time Frame: Assessed up to 30 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   31 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01634425

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Canada, Alberta
Grey Nuns Community Hospital
Edmonton, Alberta, Canada
Misericordia Community Hospital
Edmonton, Alberta, Canada
Northeast Community Health Centre (NECHC)
Edmonton, Alberta, Canada
Royal Alexandra Hospital
Edmonton, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
Sponsors and Collaborators
University of Alberta
Canadian VIGOUR Centre
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Study Chair: Paul Armstrong, MD Canadian VIGOUR Centre
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Robert Welsh, Principal Investigator, University of Alberta Identifier: NCT01634425    
Other Study ID Numbers: PROACT NSTEMI
First Posted: July 6, 2012    Key Record Dates
Last Update Posted: October 20, 2015
Last Verified: October 2015
Keywords provided by Robert Welsh, University of Alberta:
Point of Care Biomarkers
Additional relevant MeSH terms:
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Non-ST Elevated Myocardial Infarction
Myocardial Infarction
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases