Clinical trial NCT04223986: Prehospital Risk Stratification in Acute Coronary Syndromes
Official title: Prehospital Risk Stratification in Acute Coronary Syndromes- Feasibility Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Coronary Syndrome
Non-ST Elevation Myocardial Infarction (nSTEMI)
Lead sponsor: Sorlandet Hospital HF
Sponsor class: OTHER_GOV
Collaborators: name: Norwegian Air Ambulance Foundation
First posted: 2020-01-13
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective enrollment on inclusion criteria
Primary purpose: DIAGNOSTIC

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

Eligibility criteria: 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

Primary outcomes:
measure: Prehospital identification of Acute coronary syndromes
timeFrame: 1 year
measure: Transferability of images and test results
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Kristiansand
country: Norway
facility: SSHF
Study officials:
affiliation: Sorlandet Hospital Thrust and Air Ambulance foundation
name: Jarle Jortveit, PhD HOD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jacobsen L, Grenne B, Olsen RB, Jortveit J. Feasibility of prehospital identification of non-ST-elevation myocardial infarction by ECG, troponin and echocardiography. Emerg Med J. 2022 Sep;39(9):679-684. doi: 10.1136/emermed-2021-211179. Epub 2022 Jan 21.