Clinical Trials Directory

Trials / Completed

CompletedNCT05243485

Prehospital Triage of Patients With Suspected Non-ST-segment Elevation Acute Coronary Syndrome: the TRIAGE-ACS Study

Status
Completed
Phase
Study type
Observational
Enrollment
1,071 (actual)
Sponsor
Catharina Ziekenhuis Eindhoven · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

With the Emergency Medical Services (EMS), no prehospital risk stratification and triage is performed for patients suspected of having an Non-ST-segment elevation Acute Coronary Syndrome (NSTE-ACS). While the latest ESC Guidelines recommend an early invasive strategy within 24 hours for all high risk NSTE-ACS patients and same-day transfer to a PCI (Percutaneous Coronary Intervention) center. With the potential emerging logistical problem surrounding this, prehospital risk stratification and triage can have great benefits in this population as well, especially in patients with a high risk of having an NSTE-ACS. The recently validated PreHEART score makes it possible to stratify patients in a low-risk and high-risk group for having a NSTE-ACS and gives the EMS the opportunity to make triage decisions in the prehospital setting. Patients with a high risk for having an NSTE-ACS are transferred directly to an PCI-center for further diagnostic work-up. Patients with a low risk for having NSTE-ACS and transferred to the ED of the nearest hospital without PCI facilities (non-PCI center) for further diagnostic work-up, resulting in an optimization of the regional care utilization. This is the first study to focus on patients who are at a high risk of having an NSTE-ACS and to assess if whether prehospital triage using the PreHEART score is able to significantly reduce time to final invasive diagnostics and revascularization in patients in need of coronary revascularization.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTPreHEARTThe PreHEART score is validated for use in the pre-hospital setting.The score can be calculated based on five different elements: history, ECG, age, gender, and a Point-of-Care (POC)-Troponin. A minimum of 0 points and a maximum of 2 points can be scored in each element, the total PreHEART can contain a maximum of 10 points. The score of the history is based on the symptoms of the patient in accordance with the symptoms of a myocardial infarction. Based on the suspicion of ischemia on the ECG. Age will be based on the date of birth. Compared to the female gender, the male gender has higher risk of developing myocardial infarction and will be scored higher. The biomarker Troponin will be collected via intravenous access and measured using a POC-analyzer "I-Stat" from Abbott industries. In total 17 µl of blood is required to fill a cardiac Troponin I (cTnI) cartridge. Analyzing the blood will take approximately 10 minutes.

Timeline

Start date
2021-04-01
Primary completion
2022-12-19
Completion
2023-12-01
First posted
2022-02-17
Last updated
2024-02-12

Locations

1 site across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT05243485. Inclusion in this directory is not an endorsement.