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NSTEMIPhase 4PROACTNCT01634425

Providing Rapid Out of Hospital Acute Cardiovascular Treatment (PROACT)

A Phase 4 study testing Alere Triage Meter Pro in people with NSTEMI, run by University of Alberta at 5 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 31 years and older
Conditions the study is for
NSTEMI
What is being tested?
Alere Triage Meter Pro
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
601 participants
Where
5 sitesCanada
Study dates
Nov 2011to Feb 2015
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 31 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Canada5 sites

  • Grey Nuns Community Hospital

    Edmonton, Alberta

  • Misericordia Community Hospital

    Edmonton, Alberta

  • Northeast Community Health Centre (NECHC)

    Edmonton, Alberta

  • Royal Alexandra Hospital

    Edmonton, Alberta

  • University of Alberta Hospital

    Edmonton, Alberta

Other trials in Canada

About this study

Official title: 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).

Read the 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.

Conditions
NSTEMI
Being tested
Alere Triage Meter Pro
Keywords
NSTEMI, Point of Care Biomarkers
Medical subject headings
Non-ST Elevated Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Alere Triage Meter ProDevice

    Also called Point of Care Meter

    Troponin and BNP measured on point of care meter.

Study groups in NCT01634425
Study groupRoleWhat they receive
Group 1 - no pre-hospital biomarkersNo interventionStandard of Care
Group 2 - pre-hospital biomarkersExperimentalTroponin and BNP measured on a POC meter in the ambulance on the way to the hospital.
Receives: Device: Alere Triage Meter Pro

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From date of first medical contact until first appropriate therapy given, assessed up to 30 months

Secondary outcomes (6)

  1. 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).

    Measured: Assessed up to 30 months.

  2. Length of hospital stay for patients admitted to hospital

    Measured: Assessed up to 30 months

  3. In-hospital clinical events (day 7 or discharge) all-cause mortality, cardiogenic shock, heart failure, re-Myocardial infarction

    Measured: Assessed up to 30 months

  4. 30-day all-cause mortality

    Measured: Assessed up to 30 months

  5. 30 day all-cause hospitalization or re-hospitalization

    Measured: Assessed up to 30 months

  6. 30-day composite (all-cause mortality or all-cause hospitalization)

    Measured: Assessed up to 30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2012 (estimated)
  2. Study startNov 2011
  3. Primary completionFeb 2015
  4. Study completionFeb 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
601 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01634425
Sponsor's protocol ID
PROACT NSTEMI
Acronym
PROACT
Status last verified
Oct 2015
First submitted
3 Oct 2011
Last updated
20 Oct 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 28261896

  • 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.

    PubMed 26627881

  • 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.

    PubMed 26289822

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Alere Triage Meter Pro in people with NSTEMI, run by University of Alberta at 5 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01634425, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2015.

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