Providing Rapid Out of Hospital Acute Cardiovascular Treatment (PROACT)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

601 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2015-02-28

Brief Summary

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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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Detailed Description

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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

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NSTEMI

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Group 1 - no pre-hospital biomarkers

Standard of Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Group 2 - pre-hospital biomarkers

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

Group Type EXPERIMENTAL

Alere Triage Meter Pro

Intervention Type DEVICE

Troponin and BNP measured on point of care meter.

Interventions

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Alere Triage Meter Pro

Troponin and BNP measured on point of care meter.

Intervention Type DEVICE

Other Intervention Names

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Point of Care Meter

Eligibility Criteria

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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

Minimum Eligible Age

31 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No