Myocardial Infarction, STEMI
Conditions
Brief summary
This study aims to determine whether prehospital 12 lead ECG telemetry decreases the time to reperfusion in patients presenting with STEMI. A randomised controlled trial will be conducted in Gauteng and the Western Cape among 100 adult patients (\>18 years) presenting with ST-elevation myocardial infarction according to a specific inclusion and exclusion criteria outlined in the full protocol. Consenting patients will be randomly assigned to have their prehospital ECG sent to the receiving cardiac facility or not. The onset-to-reperfusion and door-to-reperfusion times will be recorded and compared between the two groups by using the Fisher's exact test and a simple unpaired Student's t-test. Data will also be subjected to multivariate analysis of variance to test for statistical significance within a variety of factors that may influence reperfusion times.
Interventions
OTHERTelemetry
OTHERNon-telemetry
Sponsors
ER24
University of Stellenbosch
Philips Healthcare
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients (\> 18 years of age) * Patients presenting within the Gauteng or Western Cape areas * Current chest pain or dyspnoea, presumed to be of cardiac origin * ST-elevation (STEMI) on the ECG (defined as ST-elevation of 0.1 mV in two or more contiguous leads).
Exclusion criteria
* Non-adult patients * Chest pain of non-cardiac aetiology (following trauma or due to a primary respiratory pathology) * Non-consent to inclusion within the study * Patients without medical aid or who states that they cannot afford private healthcare. * Non-ST-elevation myocardial infarction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reperfusion Time | At the first moment of reperfusion, from the date of randomisation up to 14 days | This outcome measures the time it takes to reperfuse a coronary artery in STEMI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prehospital Time | On arrival at hospital; from the time of randomisation up to six hours | The prehospital time is the total time from arrival at the patient to arrival at the hospital |
| Onset to reperfusion time | At the first moment of reperfusion, from the date of randomisation up to 14 days | This pertains to the time it takes from the moment of first onset of symptoms to the first moment of reperfusion |
Countries
South Africa
Outcome results
None listed