The Effect of 12 Lead ECG Telemetry on Reperfusion Time in Resource-limited Settings

Study Overview
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Brief Summary
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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.

Conditions
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Myocardial Infarction, STEMI

Intervention / Treatment
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* Other: Telemetry
* Other: Non-telemetry


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telemetry<br>In this group, participants will have a prehospital 12 lead ECG taken and sent through to the receiving facility. | Other: Telemetry<br> <br> |
| Other: Non-Telemetry<br>In this group, participants will have a prehospital 12 lead ECG taken which will not be sent through to the receiving facility. | Other: Non-telemetry<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reperfusion Time | This outcome measures the time it takes to reperfuse a coronary artery in STEMI | At the first moment of reperfusion, from the date of randomisation up to 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prehospital Time | The prehospital time is the total time from arrival at the patient to arrival at the hospital | On arrival at hospital; from the time of randomisation up to six hours | 
| Onset to reperfusion time | This pertains to the time it takes from the moment of first onset of symptoms to the first moment of reperfusion | At the first moment of reperfusion, from the date of randomisation up to 14 days |