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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

8000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2024-10-01

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.

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Detailed Description

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Conditions

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Acute Coronary Syndrome Non ST Segment Elevation Acute Coronary Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Usual care

Patients who receive usual care by EMS protocols

Group Type OTHER

Usual care

Intervention Type OTHER

Prehospital risk stratification by EMS protocols

point-of-care troponin

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

Group Type OTHER

point-of-care troponin

Intervention Type DEVICE

Prehospital risk stratification by the use of a POC-troponin

Combined risk scores

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

Group Type OTHER

Combined risk score

Intervention Type DEVICE

Prehospital risk stratification by the use of a combined clinical risk score including POC-troponin

Interventions

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Combined risk score

Prehospital risk stratification by the use of a combined clinical risk score including POC-troponin

Intervention Type DEVICE

Usual care

Prehospital risk stratification by EMS protocols

Intervention Type OTHER

point-of-care troponin

Prehospital risk stratification by the use of a POC-troponin

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes