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

Catharina Hospital

Status: Enrolling

Conditions: Acute Coronary Syndrome; Non ST Segment Elevation Acute Coronary Syndrome

Treatments: Device: point-of-care troponin; Other: Usual care; Device: Combined risk score

Study type: Interventional

Funder types: Other

Identifiers

NCT06051110

nWMO-2023.086

Details and patient eligibility

About

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.

Enrollment: 8,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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8,000 participants in 3 patient groups

Usual care

Other group

Description:

Patients who receive usual care by EMS protocols

Treatment:

Other: Usual care

point-of-care troponin

Other group

Description:

Patients in who risk-stratification was performed by the use of a point-of-care troponin in the EMS setting

Treatment:

Device: point-of-care troponin

Combined risk scores

Other group

Description:

Patients in who risk-stratification was performed by the use of a combined risk score in the EMS setting

Treatment:

Device: Combined risk score