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

Catharina Ziekenhuis Eindhoven5,239 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

5,239

Conditions

Acute Coronary Syndrome Non ST Segment Elevation Acute Coronary Syndrome

Interventions

Combined risk scoreDEVICE

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

Usual careOTHER

Prehospital risk stratification by EMS protocols

point-of-care troponinDEVICE

Prehospital risk stratification by the use of a POC-troponin

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Catharina hospital Eindhoven

Eindhoven, Netherlands

Outcomes

Primary Outcomes

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)

Time frame: During index hospitalization, up to 1 day in the ED

MACE

All cause death, myocardial infarction, revascularization

Time frame: Within 30 days

Secondary Outcomes

MACE

All cause death, myocardial infarction, revascularization

Time frame: 1 week

All cause death

Time frame: Within 30 days and 1 year follow-up

The number of participants undergoing invasive coronary angiography

Time frame: 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)

Time frame: 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)

Time frame: during 30 day follow-up after inclusion

Safety endpoints concerning intracoronary angiography and/or PCI

Bleeding complications