NCT04223986

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 30, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2018

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
Last Updated

February 8, 2023

Status Verified

November 1, 2018

Enrollment Period

11 months

First QC Date

October 23, 2018

Last Update Submit

February 3, 2023

Conditions

Acute Coronary SyndromeNon-ST Elevation Myocardial Infarction (nSTEMI)

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (1)

Ultrasound and Troponin T

OTHER

5 images transferred to cardiologist

Diagnostic Test: UltrasoundDiagnostic Test: Troponin- T quick test

Interventions

UltrasoundDIAGNOSTIC_TEST

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

Ultrasound and Troponin T
Troponin- T quick testDIAGNOSTIC_TEST

Quick test for Troponin T blood assessment

Also known as: Cobas
Ultrasound and Troponin T

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SSHF

Kristiansand, Norway

Location

Related Publications (1)

  • 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.

    PMID: 35064012DERIVED

MeSH Terms

Conditions

Acute Coronary SyndromeNon-ST Elevated Myocardial Infarction

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesMyocardial InfarctionInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Jarle Jortveit, PhD HOD

    Sorlandet Hospital Thrust and Air Ambulance foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Prospective enrollment on inclusion criteria
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2018

First Posted

January 13, 2020

Study Start

November 30, 2017

Primary Completion

November 1, 2018

Study Completion

November 30, 2018

Last Updated

February 8, 2023

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will share

Will share anonymized images upon request.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Protocol now accessable on Recearchgate
Access Criteria
Asking Primary investigator for permit
More information

Locations

NO(1)