Providing Rapid Out of Hospital Acute Cardiovascular Treatment (PROACT)

University of Alberta

Status and phase: Completed; Phase 4

Conditions: NSTEMI

Treatments: Device: Alere Triage Meter Pro

Study type: Interventional

Funder types: Other

Identifiers

NCT01634425

PROACT NSTEMI

Details and patient eligibility

About

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).

Full 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.

Enrollment: 601 patients

Sex: All

Ages: 31+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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601 participants in 2 patient groups

Group 1 - no pre-hospital biomarkers

No Intervention group

Description:

Standard of Care

Group 2 - pre-hospital biomarkers

Experimental group

Description:

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

Treatment:

Device: Alere Triage Meter Pro