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Prehospital Risk Stratification in Acute Coronary Syndromes

Not Applicable
Completed
Conditions
Acute Coronary Syndrome
Non-ST Elevation Myocardial Infarction (nSTEMI)
Interventions
Diagnostic Test: Ultrasound
Diagnostic Test: Troponin- T quick test
Registration Number
NCT04223986
Lead Sponsor
Sorlandet Hospital HF
Brief Summary

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

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

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
126
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Ultrasound and Troponin TUltrasound5 images transferred to cardiologist
Ultrasound and Troponin TTroponin- T quick test5 images transferred to cardiologist
Primary Outcome Measures
NameTimeMethod
Transferability of images and test results1 year

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.

Prehospital identification of Acute coronary syndromes1 year

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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

SSHF

🇳🇴

Kristiansand, Norway

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