Providing Rapid Out of Hospital Acute Cardiovascular Treatment (PROACT)
PROACT
1 other identifier
interventional
601
1 country
5
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2011
Typical duration for phase_4
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 3, 2011
CompletedStudy Start
First participant enrolled
November 1, 2011
CompletedFirst Posted
Study publicly available on registry
July 6, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedOctober 20, 2015
October 1, 2015
3.3 years
October 3, 2011
October 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
From date of first medical contact until first appropriate therapy given, assessed up to 30 months
Secondary Outcomes (6)
Time to administration of appropriate evidence based therapy
Assessed up to 30 months.
Length of hospital stay for patients admitted to hospital
Assessed up to 30 months
In-hospital clinical events (day 7 or discharge) all-cause mortality, cardiogenic shock, heart failure, re-Myocardial infarction
Assessed up to 30 months
30-day all-cause mortality
Assessed up to 30 months
30 day all-cause hospitalization or re-hospitalization
Assessed up to 30 months
- +1 more secondary outcomes
Other Outcomes (1)
Explore the incremental value pre-hospital BNP on primary and secondary endpoints.
Assessed up to 30 months
Study Arms (2)
Group 1 - no pre-hospital biomarkers
NO INTERVENTIONStandard of Care
Group 2 - pre-hospital biomarkers
EXPERIMENTALTroponin and BNP measured on a POC meter in the ambulance on the way to the hospital.
Interventions
Troponin and BNP measured on point of care meter.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Albertalead
- Canadian VIGOUR Centrecollaborator
Study Sites (5)
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
Related Publications (3)
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.
PMID: 28261896DERIVEDEzekowitz 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.
PMID: 26627881DERIVEDSepehrvand 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.
PMID: 26289822DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Paul Armstrong, MD
Canadian VIGOUR Centre
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 3, 2011
First Posted
July 6, 2012
Study Start
November 1, 2011
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
October 20, 2015
Record last verified: 2015-10