Individual Patient Data Meta-analysis on Prehospital Risk Assessment in Patients Suspected of Non-ST-segment Elevation Acute Coronary Syndrome

Study Overview
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Brief Summary
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Patients with a non-ST-segment elevation acute coronary syndrome (NSTE-ACS) are currently transported and admitted to the nearest emergency department (ED) for risk stratification, diagnostic workup, and treatment. Recently, several prospective studies have been performed on the diagnostic performance of point-of-care (POC)-troponin and combined risk scores (CRS) for pre-hospital risk assessment and triage of NSTE-ACS patients. Also the first intervention trials on triage decisions based on POC troponin and CRS have been performed. Initial results are indicating that prehospital triage based on these diagnostic tools is feasible and safe, although sample sizes were relatively small and underpowered to detect differences in major adverse cardiac events (MACE). The objective of this individual patient data meta-analysis is to determine the diagnostic performance of POC troponin and combined risk scores for prehospital risk assessment and triage in suspected NSTE-ACS patients.

Official Title
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Individual Patient Data Meta-analysis on Prehospital Risk Assessment in Patients Suspected of Non-ST-segment Elevation Acute Coronary Syndrome

Conditions
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Acute Coronary Syndrome, Non ST Segment Elevation Acute Coronary Syndrome

Intervention / Treatment
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* Device: Combined risk score
* Other: Usual care
* Device: point-of-care troponin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients suspected for NSTE-ACS; Prospective study Original data Presenting prehospital (EMS) Prehospital risk assessment using at least POC-troponin, performed and analyzed by EMS. Outcome data available on in-hospital ACS or MACE within 30 days. Exclusion Criteria: Enrolling only a specific subpopulation from the general ACS population Studies with less than 100 patients Studies enrolling only patients with STEMI. Studies published before 1995 / the pre-troponin era Studies performed by general practitioners.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Usual care<br>Patients who receive usual care by EMS protocols | Other: Usual care<br>* Prehospital risk stratification by EMS protocols<br>|
| Other: point-of-care troponin<br>Patients in who risk-stratification was performed by the use of a point-of-care troponin in the EMS setting | Device: point-of-care troponin<br>* Prehospital risk stratification by the use of a POC-troponin<br>|
| Other: Combined risk scores<br>Patients in who risk-stratification was performed by the use of a combined risk score in the EMS setting | Device: Combined risk score<br>* Prehospital risk stratification by the use of a combined clinical risk score including POC-troponin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with the diagnosis NSTE-ACS | Diagnosis of NSTE-ACS (NSTEMI or unstable AP) during index hospitalization (as assessed by the treating physician) | During index hospitalization, up to 1 day in the ED | 
| MACE | All cause death, myocardial infarction, revascularization | Within 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE | All cause death, myocardial infarction, revascularization | 1 week | 
| All cause death |  | Within 30 days and 1 year follow-up | 
| The number of participants undergoing invasive coronary angiography |  | During or after index hospitalisation, up to 30 days | 
| The number of participants undergoing coronary revascularisation | percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) | During or after index hospitalisation, up to 30 days | 
| Alternative diagnoses other than NSTE-ACS | If no NSTE-ACS is diagnosed, what is the alternative diagnosis (such as pulmonary embolism, aortic dissection, pneumothorax) | during 30 day follow-up after inclusion | 
| Safety endpoints concerning intracoronary angiography and/or PCI | Bleeding complications | during 30 day follow-up after intracoronary angiography and/or PCI | 
| Safety endpoints concerning intracoronary angiography and/or PCI | Contrast-induced nephropathy Possible or definite stent thrombosis Ischemic stroke Death | during 30 day follow-up after intracoronary angiography and/or PCI | 
| Safety endpoints concerning intracoronary angiography and/or PCI | Possible or definite stent thrombosis | during 30 day follow-up after intracoronary angiography and/or PCI | 
| Safety endpoints concerning intracoronary angiography and/or PCI | Ischemic stroke | during 30 day follow-up after intracoronary angiography and/or PCI | 
| Safety endpoints concerning intracoronary angiography and/or PCI | Death | during 30 day follow-up after intracoronary angiography and/or PCI | 
| Health care utilization | Number of ambulance transfers | Within 30 days after inclusion | 
| Health care utilization | Duration of hospitalisation (days) | Up to 30 days after inclusion | 
| Health care utilization | Number of double invasive coronary angiography procedures | Within 30 days after inclusion | 
| Total health care costs |  | At 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EMS, POC-troponin, Combined risk scores, Prehospital