Providing Rapid Out of Hospital Acute Cardiovascular Treatment (PROACT)

NSTEMI Clinical Trial

— PROACT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01634425
• Other study ID #: PROACT NSTEMI
• Status: Completed
• Phase: Phase 4
• First received: October 3, 2011
• Last updated: October 19, 2015
• Start date: November 2011
• Est. completion date: February 2015

Study information

• Verified date: October 2015
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 601
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 31 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• NSTEMI

Intervention

Device:
• Alere Triage Meter Pro
Troponin and BNP measured on point of care meter.

Locations

Country	Name	City	State
Canada	Grey Nuns Community Hospital	Edmonton	Alberta
Canada	Misericordia Community Hospital	Edmonton	Alberta
Canada	Northeast Community Health Centre (NECHC)	Edmonton	Alberta
Canada	Royal Alexandra Hospital	Edmonton	Alberta
Canada	University of Alberta Hospital	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	Canadian VIGOUR Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Explore the incremental value pre-hospital BNP on primary and secondary endpoints.		Assessed up to 30 months	No
Primary	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.	From date of first medical contact until first appropriate therapy given, assessed up to 30 months	No
Secondary	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).	Assessed up to 30 months.	No
Secondary	Length of hospital stay for patients admitted to hospital		Assessed up to 30 months	No
Secondary	In-hospital clinical events (day 7 or discharge) all-cause mortality, cardiogenic shock, heart failure, re-Myocardial infarction		Assessed up to 30 months	No
Secondary	30-day all-cause mortality		Assessed up to 30 months	No
Secondary	30 day all-cause hospitalization or re-hospitalization		Assessed up to 30 months	No
Secondary	30-day composite (all-cause mortality or all-cause hospitalization)		Assessed up to 30 months	No