Clinical trial NCT01634425: Providing Rapid Out of Hospital Acute Cardiovascular Treatment (PROACT)
Official title: Providing Rapid Out of Hospital Acute Cardiovascular Treatment (PROACT) Novel Proximal Pathways for Non ST Elevation Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: NSTEMI
Keywords: NSTEMI
Point of Care Biomarkers
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Canadian VIGOUR Centre
First posted: 2012-07-06
Enrollment: 601
Sex: ALL
Minimum age (years): 31
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility 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

Primary outcomes:
measure: Time from first medical contact to final patient disposition.
timeFrame: From date of first medical contact until first appropriate therapy given, assessed up to 30 months
Secondary outcomes:
measure: Time to administration of appropriate evidence based therapy
timeFrame: Assessed up to 30 months.
measure: Length of hospital stay for patients admitted to hospital
timeFrame: Assessed up to 30 months
measure: In-hospital clinical events (day 7 or discharge) all-cause mortality, cardiogenic shock, heart failure, re-Myocardial infarction
timeFrame: Assessed up to 30 months
measure: 30-day all-cause mortality
timeFrame: Assessed up to 30 months
measure: 30 day all-cause hospitalization or re-hospitalization
timeFrame: Assessed up to 30 months
measure: 30-day composite (all-cause mortality or all-cause hospitalization)
timeFrame: Assessed up to 30 months
Other outcomes:
measure: Explore the incremental value pre-hospital BNP on primary and secondary endpoints.
timeFrame: Assessed up to 30 months
Locations:
city: Edmonton
country: Canada
facility: Grey Nuns Community Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Misericordia Community Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Northeast Community Health Centre (NECHC)
state: Alberta
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
Study officials:
affiliation: Canadian VIGOUR Centre
name: Paul Armstrong, MD
role: STUDY_CHAIR
References:
citation: Sepehrvand N, Zheng Y, Armstrong PW, Welsh RC, Ezekowitz JA. Identifying Low-risk Patients for Early Discharge From Emergency Department Without Using Subjective Descriptions of Chest Pain: Insights From Providing Rapid Out of Hospital Acute Cardiovascular Treatment (PROACT) 3 and 4 Trials. Acad Emerg Med. 2017 Jun;24(6):691-700. doi: 10.1111/acem.13183. Epub 2017 May 12.
citation: Ezekowitz JA, Welsh RC, Weiss D, Chan M, Keeble W, Khadour F, Sharma S, Tymchak W, Sookram S, Brass N, Knapp D, Koshy TL, Zheng Y, Armstrong PW. Providing Rapid Out of Hospital Acute Cardiovascular Treatment 4 (PROACT-4). J Am Heart Assoc. 2015 Dec 1;4(12):e002859. doi: 10.1161/JAHA.115.002859.
citation: Sepehrvand N, Zheng Y, Armstrong PW, Welsh R, Goodman SG, Tymchak W, Khadour F, Chan M, Weiss D, Ezekowitz JA. Alignment of site versus adjudication committee-based diagnosis with patient outcomes: Insights from the Providing Rapid Out of Hospital Acute Cardiovascular Treatment 3 trial. Clin Trials. 2016 Apr;13(2):140-8. doi: 10.1177/1740774515601437. Epub 2015 Aug 19.