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Prehospital Risk Stratification in Acute Coronary Syndromes

Prehospital Risk Stratification in Acute Coronary Syndromes- Feasibility Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04223986
Acronym
Pre-ACS
Enrollment
126
Registered
2020-01-13
Start date
2017-11-30
Completion date
2018-11-30
Last updated
2023-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

Interventions

DIAGNOSTIC_TESTUltrasound

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

DIAGNOSTIC_TESTTroponin- T quick test

Quick test for Troponin T blood assessment

Sponsors

Norwegian Air Ambulance Foundation
CollaboratorOTHER
Sorlandet Hospital HF
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

Prospective enrollment on inclusion criteria

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Prehospital identification of Acute coronary syndromes1 yearEvaluate 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.
Transferability of images and test results1 yearMeasure 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.

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026