Prehospital Risk Stratification in Acute Coronary Syndromes (Pre-ACS)
Primary Purpose
Acute Coronary Syndrome, Non-ST Elevation Myocardial Infarction (nSTEMI)
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Ultrasound
Troponin- T quick test
Sponsored by
About this trial
This is an interventional diagnostic trial for Acute Coronary Syndrome
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
Sites / Locations
- SSHF
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Ultrasound and Troponin T
Arm Description
5 images transferred to cardiologist
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04223986
First Posted
October 23, 2018
Last Updated
February 3, 2023
Sponsor
Sorlandet Hospital HF
Collaborators
Norwegian Air Ambulance Foundation
1. Study Identification
Unique Protocol Identification Number
NCT04223986
Brief Title
Prehospital Risk Stratification in Acute Coronary Syndromes
Acronym
Pre-ACS
Official Title
Prehospital Risk Stratification in Acute Coronary Syndromes- Feasibility Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
November 30, 2017 (Actual)
Primary Completion Date
November 1, 2018 (Actual)
Study Completion Date
November 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sorlandet Hospital HF
Collaborators
Norwegian Air Ambulance Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome, Non-ST Elevation Myocardial Infarction (nSTEMI)
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective enrollment on inclusion criteria
Masking
None (Open Label)
Allocation
N/A
Enrollment
126 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ultrasound and Troponin T
Arm Type
Other
Arm Description
5 images transferred to cardiologist
Intervention Type
Diagnostic Test
Intervention Name(s)
Ultrasound
Intervention Description
decide between the need for intervention or not (Percutaneous coronary intervention)
Intervention Type
Diagnostic Test
Intervention Name(s)
Troponin- T quick test
Other Intervention Name(s)
Cobas
Intervention Description
Quick test for Troponin T blood assessment
Primary Outcome Measure Information:
Title
Prehospital identification of Acute coronary syndromes
Description
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.
Time Frame
1 year
Title
Transferability of images and test results
Description
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.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jarle Jortveit, PhD HOD
Organizational Affiliation
Sorlandet Hospital Thrust and Air Ambulance foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
SSHF
City
Kristiansand
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Will share anonymized images upon request.
IPD Sharing Time Frame
Protocol now accessable on Recearchgate
IPD Sharing Access Criteria
Asking Primary investigator for permit
IPD Sharing URL
https://www.researchgate.net/
Citations:
PubMed Identifier
35064012
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.
Results Reference
derived
Learn more about this trial
Prehospital Risk Stratification in Acute Coronary Syndromes
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