Acute Coronary Syndrome, Non ST Segment Elevation Acute Coronary Syndrome
Conditions
Keywords
EMS, POC-troponin, Combined risk scores, Prehospital
Brief summary
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.
Interventions
DEVICECombined risk score
Prehospital risk stratification by the use of a combined clinical risk score including POC-troponin
OTHERUsual care
Prehospital risk stratification by EMS protocols
DEVICEpoint-of-care troponin
Prehospital risk stratification by the use of a POC-troponin
Sponsors
Catharina Ziekenhuis Eindhoven
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Patients suspected for NSTE-ACS; 2. Prospective study 3. Original data 4. Presenting prehospital (EMS) 5. Prehospital risk assessment using at least POC-troponin, performed and analyzed by EMS. 6. Outcome data available on in-hospital ACS or MACE within 30 days.
Exclusion criteria
1. Enrolling only a specific subpopulation from the general ACS population 2. Studies with less than 100 patients 3. Studies enrolling only patients with STEMI. 4. Studies published before 1995 / the pre-troponin era 5. Studies performed by general practitioners.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MACE | Within 30 days | All cause death, myocardial infarction, revascularization |
| Number of participants with the diagnosis NSTE-ACS | During index hospitalization, up to 1 day in the ED | Diagnosis of NSTE-ACS (NSTEMI or unstable AP) during index hospitalization (as assessed by the treating physician) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The number of participants undergoing coronary revascularisation | During or after index hospitalisation, up to 30 days | percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) |
| Alternative diagnoses other than NSTE-ACS | during 30 day follow-up after inclusion | If no NSTE-ACS is diagnosed, what is the alternative diagnosis (such as pulmonary embolism, aortic dissection, pneumothorax) |
| Safety endpoints concerning intracoronary angiography and/or PCI | during 30 day follow-up after intracoronary angiography and/or PCI | Bleeding complications |
| Health care utilization | Within 30 days after inclusion | Number of ambulance transfers |
| Total health care costs | At 30 days | — |
| All cause death | Within 30 days and 1 year follow-up | — |
| MACE | 1 week | All cause death, myocardial infarction, revascularization |
| The number of participants undergoing invasive coronary angiography | During or after index hospitalisation, up to 30 days | — |
Countries
Netherlands
Contacts
PRINCIPAL_INVESTIGATORPieter-Jan Vlaar, MD, PhD
Catharina Ziekenhuis Eindhoven
Outcome results
None listed