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

Karolinska Institute

Status: Completed

Conditions: Myocardial Infarction; STEMI

Treatments: Other: Telemetry; Other: Non-telemetry

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02441582

3-1178/2014

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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19 participants in 2 patient groups

Telemetry

Experimental group

Description:

In this group, participants will have a prehospital 12 lead ECG taken and sent through to the receiving facility.

Treatment:

Other: Telemetry

Non-Telemetry

Other group

Description:

In this group, participants will have a prehospital 12 lead ECG taken which will not be sent through to the receiving facility.

Treatment:

Other: Non-telemetry