New mobile application reduces the time lost in patients with a heart attack
| ISRCTN | ISRCTN40431563 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40431563 |
| Protocol serial number | appSTEMI trial |
| Sponsor | Presov University, Faculty of Health Care |
| Funder | Presov University |
- Submission date
- 11/03/2018
- Registration date
- 04/05/2018
- Last edited
- 04/05/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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)
Contact information
Scientific
Teaching Hospital of J.A.Reiman
Cardiology Clinic
Holleho 14
Presov
08001
Slovakia
| 0000-0002-1678-3420 |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Longitudinal case series observational single centre study |
| Secondary study design | Case series |
| Study type | Participant information sheet |
| Scientific title | Significant benefits of new communication technology for time delay management in STEMI patients. |
| Study objectives | 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. |
| Health condition(s) or problem(s) studied | 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(s) |
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. |
| Key secondary outcome measure(s) |
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. |
| Completion date | 12/09/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 220 |
| Key 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 |
| Key exclusion criteria | No specified exclusion criteria. |
| Date of first enrolment | 01/08/2016 |
| Date of final enrolment | 31/12/2016 |
Locations
Countries of recruitment
- Slovakia
Study participating centre
Presov
08001
Slovakia
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |