New mobile application reduces the time lost in patients with a heart attack

ISRCTN	ISRCTN40431563
DOI	https://doi.org/10.1186/ISRCTN40431563
Secondary identifying numbers	appSTEMI trial

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

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

Dr Martin Studencan
Scientific

Teaching Hospital of J.A.Reiman
Cardiology Clinic
Holleho 14
Presov
08001
Slovakia

ORCID ID	0000-0002-1678-3420

Study information

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
Participant information sheet	No participant information sheet available.
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	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
Completion date	12/09/2017

Eligibility

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
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

Teaching Hospital of J. A. Reiman, Cardiology Clinic

Holleho 14
Presov
08001
Slovakia

Sponsor information

Presov University, Faculty of Health Care
University/education

Partizanska 1
Presov
08001
Slovakia

"ROR"	https://ror.org/02ndfsn03

Funders

Funder type

University/education

Presov University

No information available

Results and Publications

Intention to publish date	15/05/2018
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Planned publication in a high-impact peer reviewed journal.
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.