Providing Rapid Out of Hospital Acute Cardiovascular Treatment (PROACT)
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Purpose
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) and acute heart failure (AHF) .
| Condition | Intervention | Phase |
|---|---|---|
|
NSTEMI Acute Heart Failure |
Device: Alere Triage Meter Pro |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Providing Rapid Out of Hospital Acute Cardiovascular Treatment (PROACT) NSTEMI and AHF Biomarkers Study |
- Time from first medical contact to administration of appropriate evidence based therapy. [ Time Frame: From date of first medical contact until first appropriate therapy given, assessed up to 30 months ] [ Designated as safety issue: No ]First medical contact is defined as arrival of the paramedics on scene. First appropriate therapy for NSTEMI is defined as: receiving oral antiplatelet agent (excluding ASA) or intravenous/subcutaneous antithrombotic agents. First appropriate therapy for AHF is defined as: IV nitroglycerin, or oral or intravenous furosemide. Final disposition for other diagnoses is a diagnosis, institution of therapy for other diagnosis or admission/discharge for that diagnosis.
- Time from first medical contact to clinical diagnosis [ Time Frame: From time of first medical contact to clinical diagnosis, assessed up to 30 months ] [ Designated as safety issue: No ]
- Time from first medical contact to hospital admission or discharge from emergency - all patients [ Time Frame: From time of first medical contact up to hospital admission or discharge, whichever comes first, assessed up to 30 months ] [ Designated as safety issue: No ]
- Length of hospital stay [ Time Frame: From date of first medical contact until hospital discharge, assessed up to 30 months ] [ Designated as safety issue: No ]
- In-hospital clinical events - death, shock, HF, re-MI [ Time Frame: From date of first medical contact until hospital discharge, assessed up to 30 months ] [ Designated as safety issue: No ]
- 30-day and 1 year mortality [ Time Frame: From date of first medical contact until 1 year or death, whichever comes first, assessed up to 30 months ] [ Designated as safety issue: No ]
- 30 day hospitalization or re-hospitalization [ Time Frame: From date of first medical contact until 30 days, assessed up to 30 months ] [ Designated as safety issue: No ]
- Cost analysis of implementing pre-hospital point of care analysis [ Time Frame: From date of first medical contact until 1 year, assessed up to 30 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1800 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Group 1 - no pre-hospital biomarkers
Standard of Care
|
|
|
Experimental: Group 2 - pre-hospital biomarkers
Troponin and BNP measured on a POC meter in the ambulance on the way to the hospital.
|
Device: Alere Triage Meter Pro
Troponin and BNP measured on point of care meter.
Other Name: Point of Care Meter
|
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 or AHF through utilization of systematic clinical assessment, pre-hospital 12 lead electrocardiogram and point of care measurement of biomarkers. We hypothesize that establishing a pre-hospital diagnosis in these conditions 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| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient activates pre-hospital EMS for symptoms of acute chest discomfort or dyspnea for which acute coronary disease or heart failure is deemed to be the most probable diagnosis.
- Patient is older than 18
- Patients able to give informed consent
Exclusion Criteria:
- Patient with documented ST elevation on the initial 12 lead ECG
- Patients with a prior diagnosis that is compatible with recurrent symptoms of dyspnea or chest discomfort i.e. severe asthma, etc.
Contacts and Locations| Contact: Robert C Welsh, MD | 780-407-3613 | robert.welsh@albertahealthservices.ca |
| Canada, Alberta | |
| University of Alberta Hospital | Recruiting |
| Edmonton, Alberta, Canada | |
| Contact: Robert C Welsh, MD 780-407-3613 robert.welsh@albertahealthservices.ca | |
| Royal Alexandra Hospital | Recruiting |
| Edmonton, Alberta, Canada | |
| Contact: Rob Welsh, MD 780-407-3613 robert.welsh@albertahealthservices.ca | |
| Misericordia Community Hospital | Recruiting |
| Edmonton, Alberta, Canada | |
| Contact: Rob Welsh, MD 780-407-3613 robert.welsh@albertahealthservices.ca | |
| Northeast Community Health Centre (NECHC) | Recruiting |
| Edmonton, Alberta, Canada | |
| Contact: Rob Welsh, MD 780-407-3613 robert.welsh@albertahealthservices.ca | |
| Grey Nuns Community Hospital | Recruiting |
| Edmonton, Alberta, Canada | |
| Contact: Rob Welsh, MD 780-407-3613 robert.welsh@albertahealthservices.ca | |
| Study Chair: | Paul Armstrong, MD | Canadian VIGOUR Centre |
More Information
No publications provided
| Responsible Party: | Robert Welsh, Principal Investigator, University of Alberta |
| ClinicalTrials.gov Identifier: | NCT01634425 History of Changes |
| Other Study ID Numbers: | PROACT NSTEMI & AHF |
| Study First Received: | October 3, 2011 |
| Last Updated: | July 2, 2012 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by University of Alberta:
|
NSTEMI Acute Heart Failure Point of Care Biomarkers |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 23, 2013