Prehospital Risk Stratification in Acute Coronary Syndromes

Acute Coronary Syndrome Clinical Trial

— Pre-ACS  

Official title:

Prehospital Risk Stratification in Acute Coronary Syndromes- Feasibility Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04223986
• Other study ID #: 17/05178-2 - 522
• Status: Completed
• Phase: N/A
• Start date: November 30, 2017
• Est. completion date: November 30, 2018

Study information

• Verified date: November 2018
• Source: Sorlandet Hospital HF
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: November 30, 2018
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• Ultrasound
decide between the need for intervention or not (Percutaneous coronary intervention)
• Troponin- T quick test
Quick test for Troponin T blood assessment

Locations

Country	Name	City	State
Norway	SSHF	Kristiansand

Sponsors (2)

Lead Sponsor	Collaborator
Sorlandet Hospital HF	Norwegian Air Ambulance Foundation

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prehospital identification of Acute coronary syndromes	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.	1 year
Primary	Transferability of images and test results	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.	1 year