search
Back to results

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

Primary Purpose

NSTEMI

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Alere Triage Meter Pro
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for NSTEMI focused on measuring NSTEMI, Point of Care Biomarkers

Eligibility Criteria

31 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Group 1 - no pre-hospital biomarkers

Group 2 - pre-hospital biomarkers

Arm Description

Standard of Care

Troponin and BNP measured on a POC meter in the ambulance on the way to the hospital.

Outcomes

Primary Outcome Measures

Time from first medical contact to final patient disposition.
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
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
In-hospital clinical events (day 7 or discharge) all-cause mortality, cardiogenic shock, heart failure, re-Myocardial infarction
30-day all-cause mortality
30 day all-cause hospitalization or re-hospitalization
30-day composite (all-cause mortality or all-cause hospitalization)

Full Information

First Posted
October 3, 2011
Last Updated
October 19, 2015
Sponsor
University of Alberta
Collaborators
Canadian VIGOUR Centre
search

1. Study Identification

Unique Protocol Identification Number
NCT01634425
Brief Title
Providing Rapid Out of Hospital Acute Cardiovascular Treatment (PROACT)
Acronym
PROACT
Official Title
Providing Rapid Out of Hospital Acute Cardiovascular Treatment (PROACT) Novel Proximal Pathways for Non ST Elevation Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alberta
Collaborators
Canadian VIGOUR Centre

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NSTEMI
Keywords
NSTEMI, Point of Care Biomarkers

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
601 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 - no pre-hospital biomarkers
Arm Type
No Intervention
Arm Description
Standard of Care
Arm Title
Group 2 - pre-hospital biomarkers
Arm Type
Experimental
Arm Description
Troponin and BNP measured on a POC meter in the ambulance on the way to the hospital.
Intervention Type
Device
Intervention Name(s)
Alere Triage Meter Pro
Other Intervention Name(s)
Point of Care Meter
Intervention Description
Troponin and BNP measured on point of care meter.
Primary Outcome Measure Information:
Title
Time from first medical contact to final patient disposition.
Description
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 Frame
From date of first medical contact until first appropriate therapy given, assessed up to 30 months
Secondary Outcome Measure Information:
Title
Time to administration of appropriate evidence based therapy
Description
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).
Time Frame
Assessed up to 30 months.
Title
Length of hospital stay for patients admitted to hospital
Time Frame
Assessed up to 30 months
Title
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
Title
30-day all-cause mortality
Time Frame
Assessed up to 30 months
Title
30 day all-cause hospitalization or re-hospitalization
Time Frame
Assessed up to 30 months
Title
30-day composite (all-cause mortality or all-cause hospitalization)
Time Frame
Assessed up to 30 months
Other Pre-specified Outcome Measures:
Title
Explore the incremental value pre-hospital BNP on primary and secondary endpoints.
Time Frame
Assessed up to 30 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
31 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria 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. Patient is older than 30 years of age Patient is able to give informed consent Exclusion Criteria Patient with documented ST elevation on the initial 12 lead ECG Patient with a prior diagnosis that is compatible with another disease i.e. severe asthma, etc. Patient with Central Nervous System symptoms or syncope Patient with cardiac arrest, ventricular tachycardia or atrial fibrillation with heart rate > 110 bpm
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Armstrong, MD
Organizational Affiliation
Canadian VIGOUR Centre
Official's Role
Study Chair
Facility Information:
Facility Name
Grey Nuns Community Hospital
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Misericordia Community Hospital
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Northeast Community Health Centre (NECHC)
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Royal Alexandra Hospital
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
28261896
Citation
Sepehrvand N, Zheng Y, Armstrong PW, Welsh RC, Ezekowitz JA. Identifying Low-risk Patients for Early Discharge From Emergency Department Without Using Subjective Descriptions of Chest Pain: Insights From Providing Rapid Out of Hospital Acute Cardiovascular Treatment (PROACT) 3 and 4 Trials. Acad Emerg Med. 2017 Jun;24(6):691-700. doi: 10.1111/acem.13183. Epub 2017 May 12.
Results Reference
derived
PubMed Identifier
26627881
Citation
Ezekowitz JA, Welsh RC, Weiss D, Chan M, Keeble W, Khadour F, Sharma S, Tymchak W, Sookram S, Brass N, Knapp D, Koshy TL, Zheng Y, Armstrong PW. Providing Rapid Out of Hospital Acute Cardiovascular Treatment 4 (PROACT-4). J Am Heart Assoc. 2015 Dec 1;4(12):e002859. doi: 10.1161/JAHA.115.002859.
Results Reference
derived
PubMed Identifier
26289822
Citation
Sepehrvand N, Zheng Y, Armstrong PW, Welsh R, Goodman SG, Tymchak W, Khadour F, Chan M, Weiss D, Ezekowitz JA. Alignment of site versus adjudication committee-based diagnosis with patient outcomes: Insights from the Providing Rapid Out of Hospital Acute Cardiovascular Treatment 3 trial. Clin Trials. 2016 Apr;13(2):140-8. doi: 10.1177/1740774515601437. Epub 2015 Aug 19.
Results Reference
derived

Learn more about this trial

Providing Rapid Out of Hospital Acute Cardiovascular Treatment (PROACT)

We'll reach out to this number within 24 hrs