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Clinical Trials/NCT01634425
NCT01634425
Completed
Phase 4

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

University of Alberta5 sites in 1 country601 target enrollmentNovember 2011
ConditionsNSTEMI

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
NSTEMI
Sponsor
University of Alberta
Enrollment
601
Locations
5
Primary Endpoint
Time from first medical contact to final patient disposition.
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2011
End Date
February 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Robert Welsh

Principal Investigator

University of Alberta

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

  • 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)
  • 30-day composite (all-cause mortality or all-cause hospitalization)(Assessed up to 30 months)

Study Sites (5)

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