Prehospital Risk Stratification in Acute Coronary Syndromes

Study Overview
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Brief Summary
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A feasibility study of prehospital echocardiographic examination and point-of-care troponin analysis, conducted by paramedics, in patients with suspected acute coronary syndrome. Echocardiographic images are sent together with information of TnT values and ECG signs to there cardiologist on call, deciding for immediate Cath lab (PCI) evaluation or local hospital evaluation.

Detailed Description
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Assessing the feasibility and sensitivity and specificity of prehospital risk stratification by echocardiography and Troponin T in patients with suspected acute coronary syndrome, compared with conventional in-hospital evaluation. The trial will be conducted at Sørlandet Hospital, Norway. One acute care ambulance in Agder county will be equipped with a high-end cardiac ultrasound scanner with wireless communication to the cardiac centre/cardiologist, and a point-of-care troponin T quantitative analysis kit Paramedics will be offered a comprehensive hands-on course in cardiac ultrasound image acquisition by an echo-technician and a cardiologist. Similar, a short course will be given in point-of-care troponin analysis. Imaging quality Communication between paramedic and cardiologist established Image transfer and interpretation by cardiologist functional Technical problems addressed and solved in collaboration with manufacturer

Official Title
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Prehospital Risk Stratification in Acute Coronary Syndromes- Feasibility Trial

Conditions
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Acute Coronary Syndrome, Non-ST Elevation Myocardial Infarction (nSTEMI)

Intervention / Treatment
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* Diagnostic Test: Ultrasound
* Diagnostic Test: Troponin- T quick test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients presenting to the medical dispatch center (AMK) with chest pain; Norwegian medical index criteria A10.2- A10.11 Men and women Age ≥ 18 Informed consent for participation Examined by paramedics in a prehospital setting due to newly onset (<12 hours) chest pain (lasting for >20 min) and suspected AMI Exclusion Criteria: Any condition which interfere with the ability to cooperate Hemodynamic instability Severe mental disorder Pregnancy or breast-feeding STEMI Obvious non-cardiac origin of the chest pain

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective enrollment on inclusion criteria
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Ultrasound and Troponin T<br>5 images transferred to cardiologist | Diagnostic Test: Ultrasound<br>* decide between the need for intervention or not (Percutaneous coronary intervention)<br>Diagnostic Test: Troponin- T quick test<br>* Quick test for Troponin T blood assessment<br>* Other names: Cobas;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prehospital identification of Acute coronary syndromes | Evaluate the feasibility of paramedics performing POC Hs-cTnT measurements and focused TTE for prehospital NSTE-ACS risk stratification. Investigate if focused prehospital transthoracic echocardiography (TTE) images achieved by paramedics could be transferred to the in-hospital cardiologist for diagnostic evaluation, and test if this, in combination with a point-of-care (POC) high-sensitive Troponin-T (Hs-cTnT ) test, facilitates prehospital identification of high risk NSTE-ACS. Measure: number of prehospital NSTEMI discovered or missed on the prehospital evaluation, through patient journal review at day 30. and 90. | 1 year | 
| Transferability of images and test results | Measure if focused prehospital transthoracic echocardiography (TTE) images achieved by paramedics could be transferred to the in-hospital cardiologist for diagnostic evaluation in combination with a point-of-care (POC) high-sensitive Troponin-T (Hs-cTnT ) test. Measure: Quality assessment on 1-5 scale. count of interpretable images. | 1 year |