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

October 3, 2011
September 24, 2013
November 2011
December 2014   (final data collection date for primary outcome measure)
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.

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.
Complete list of historical versions of study NCT01634425 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Explore the incremental value pre-hospital BNP on primary and secondary endpoints. [ Time Frame: Assessed up to 30 months ] [ Designated as safety issue: No ]
Not Provided
 
Providing Rapid Out of Hospital Acute Cardiovascular Treatment (PROACT)
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).

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
NSTEMI
Device: Alere Triage Meter Pro
Troponin and BNP measured on point of care meter.
Other Name: Point of Care Meter
  • 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.
    Intervention: Device: Alere Triage Meter Pro
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1100
July 2015
December 2014   (final data collection date for primary outcome measure)

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
Both
31 Years and older
No
Contact: Robert C Welsh, MD 780-407-3613 robert.welsh@albertahealthservices.ca
Canada
 
NCT01634425
PROACT NSTEMI
No
Robert Welsh, University of Alberta
University of Alberta
Canadian VIGOUR Centre
Study Chair: Paul Armstrong, MD Canadian VIGOUR Centre
University of Alberta
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP