Prehospital Risk Stratification in Acute Coronary Syndromes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-30

Study Completion Date

2018-11-30

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.

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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

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective enrollment on inclusion criteria

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Ultrasound and Troponin T

5 images transferred to cardiologist

Group Type OTHER

Ultrasound

Intervention Type DIAGNOSTIC_TEST

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

Troponin- T quick test

Intervention Type DIAGNOSTIC_TEST

Quick test for Troponin T blood assessment

Interventions

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Ultrasound

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

Intervention Type DIAGNOSTIC_TEST

Troponin- T quick test

Quick test for Troponin T blood assessment

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Cobas

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No