Individual Patient Data Meta-analysis on Prehospital Risk Assessment in Patients Suspected of Non-ST-segment Elevation Acute Coronary Syndrome
- Conditions
- Non ST Segment Elevation Acute Coronary SyndromeAcute Coronary Syndrome
- Interventions
- Device: Combined risk scoreOther: Usual careDevice: point-of-care troponin
- Registration Number
- NCT06051110
- Lead Sponsor
- Catharina Ziekenhuis Eindhoven
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 8000
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Combined risk scores Combined risk score Patients in who risk-stratification was performed by the use of a combined risk score in the EMS setting Usual care Usual care Patients who receive usual care by EMS protocols point-of-care troponin point-of-care troponin Patients in who risk-stratification was performed by the use of a point-of-care troponin in the EMS setting
- Primary Outcome Measures
Name Time Method 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)
MACE Within 30 days All cause death, myocardial infarction, revascularization
- Secondary Outcome Measures
Name Time Method Health care utilization Within 30 days after inclusion Number of double invasive coronary angiography procedures
MACE 1 week All cause death, myocardial infarction, revascularization
Total health care costs At 30 days 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 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 Death
Trial Locations
- Locations (1)
Catharina hospital Eindhoven
🇳🇱Eindhoven, Netherlands