Plain English Summary
Background and study aims
There is specific type of heart attack, called STEMI, which requires immediate medical help. The special procedure called primary PCI, which aims to quickly restore blood flow and function, can remarkably improve prognosis and even save the life of the patient. Time interval to the procedure is crucial.
A new smartphone based communication technology enables an ECG transmission (test to check the heart’s rhythm and electrical activity) to be sent by paramedics in the field to doctors in the specialised centre. They can remotely confirm the STEMI diagnosis so the patient is transferred directly to the lab where PCI procedure can be performed within recommended time interval. This study aims to compare two periods, the first from 2015 when communication technology is not used by paramedics and second from 2016, when all emergency service vehicles in the area are equipped with the technology.
Who can participate?
Adults suffering from chest pain
What does the study involve?
Participants suffering from chest pain are responded to by the emergency services. Paramedics responding to those in the first time period (2015) did not use any smartphone technology so participants receive treatment as normal.
When responding to participants in the second time period (2016) paramedics use smart phone technology to communicate with the doctors at the hospital. This allows quicker delivery of patients to the appropriate treatment location.
What are the possible benefits and risks of participating?
Participants may benefit from direct transfer to the necessary location, so decreased time lost and improved prognosis. There are no direct risks for patients as the study is observational.
Where is the study run from?
Teaching Hospital of J. A. Reiman (Slovakia)
When is the study starting and how long is it expected to run for?
May 2016 – September 2017
Who is funding the study?
Presov University (Slovakia)
Who is the main contact?
Dr Martin Studencan (Scientific)
Study website
Contact information
Type
Scientific
Contact name
Dr Martin Studencan
ORCID ID
http://orcid.org/0000-0002-1678-3420
Contact details
Teaching Hospital of J.A.Reiman
Cardiology Clinic
Holleho 14
Presov
08001
Slovakia
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
appSTEMI trial
Study information
Scientific title
Significant benefits of new communication technology for time delay management in STEMI patients.
Acronym
Study hypothesis
Use of the smartphone telemedicine to facilitate prehospital diagnosis of myocardial infarction (STEMI) could improve total ischemic period and prognosis of patients.
Ethics approval(s)
Ethics approval not required: retrospective observational study, only anonymous data analysis and reporting. No medication but standard medical care was applied. Use of new communication technology has been used.
Study design
Longitudinal case series observational single centre study
Primary study design
Observational
Secondary study design
Case series
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
No participant information sheet available.
Condition
ST-elevation myocardial infarction (STEMI)
Intervention
Paramedics in the field spend 2 months responding to chest pain calls using no remote ECG evaluation and medical treatment as normal. They then spend 5 months responding to calls of chest pain, using smartphone technology to communicate with specialists in the local cardiocentre, aiming to evaluate the ECG and establish a diagnosis of STEMI remotely. If this is confirmed, they arrange primary transportation of the patient to the cathlab.
Intervention type
Procedure/Surgery
Primary outcome measure
1. Total ischemic period measured using time interval between symptom onset (according to the patient, stated in medical records) and time of PCI procedure (moment of PCI wire insertion) stated in medical records by cardiologist performing the procedure.
2. Proportion of unwanted secondary transportation calculated using information from medical records. The number of STEMI patients transported to the cardiocentre by EMS via secondary transportations is compared to the number of all STEMI patients.
Secondary outcome measures
Technological reliability of the communication technology is assessed by measurement of an ECG transmission time. If the transmission fails or if it overcame 3 minutes – it is considered to be unsuccessful. Transmission within 3 minutes is considered to be successful.
Overall study start date
10/05/2016
Overall study end date
12/09/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Adult age 45 - 86
2. Suffering from chest pain
3. Visited by EMS staff once ECG has been recorded and suspicion raised about STEMI
Participant type(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
160 patient of the analysed group from 2016 compared to 60 patients of the reference group from 2015
Participant exclusion criteria
No specified exclusion criteria.
Recruitment start date
01/08/2016
Recruitment end date
31/12/2016
Locations
Countries of recruitment
Slovakia
Study participating centre
Teaching Hospital of J. A. Reiman, Cardiology Clinic
Holleho 14
Presov
08001
Slovakia
Sponsor information
Organisation
Presov University, Faculty of Health Care
Sponsor details
Partizanska 1
Presov
08001
Slovakia
Sponsor type
University/education
Website
ROR
Funders
Funder type
University/education
Funder name
Presov University
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal.
Intention to publish date
15/05/2018
Individual participant data (IPD) sharing plan
The datasets generated during and/or analysed during the current study will be available upon request, once the study is published up to six months, from the first author ass.prof.Martin Studencan, M.D.,PhD., email adress studencan@fnsppresov.sk
It relates to anonymised data showing recorded clinical time intervals, gender, age, ejection fraction, ECG transmission time and yes/no final STEMI diagnosis confirmation.
IPD sharing plan summary
Available on request
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|