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Completed

NCT Number: NCT01634425

Providing Rapid Out of Hospital Acute Cardiovascular Treatment (PROACT)

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).

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Key information

Age range

31 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Grey Nuns Community Hospital, Edmonton, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alere Triage Meter Pro

Device

Troponin and BNP measured on point of care meter.

Other names: Point of Care Meter

Primary outcomes

  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 outcomes

  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 outcomes

  1. Explore the incremental value pre-hospital BNP on primary and secondary endpoints.

    Time frame: Assessed up to 30 months

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Canadian VIGOUR Centre

Registry information

Official study title

Providing Rapid Out of Hospital Acute Cardiovascular Treatment (PROACT) Novel Proximal Pathways for Non ST Elevation Myocardial Infarction

Acronym: PROACT

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jul 6, 2012
Registry last updated
Oct 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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