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Completed

NCT Number: NCT04223986

Prehospital Risk Stratification in Acute Coronary Syndromes

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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound

Diagnostic Test

decide between the need for intervention or not (Percutaneous coronary intervention)

Troponin- T quick test

Diagnostic Test

Quick test for Troponin T blood assessment

Other names: Cobas

Primary outcomes

  1. Prehospital identification of Acute coronary syndromes

    Time frame: 1 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.

  2. Transferability of images and test results

    Time frame: 1 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.

Sponsors and collaborators

Lead sponsor

Sorlandet Hospital HF

Other Gov

Collaborators

  • Norwegian Air Ambulance Foundation

Registry information

Official study title

Prehospital Risk Stratification in Acute Coronary Syndromes- Feasibility Trial

Acronym: Pre-ACS

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 13, 2020
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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