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

Not Applicable

Completed

• Conditions: STEMI; Myocardial Infarction
• Interventions: Other: Telemetry; Other: Non-telemetry

• Registration Number: NCT02441582
• Lead Sponsor: Karolinska Institutet

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2015-05-05
• Study First Submitted QC: 2015-05-07
• Study First Posted: 2015-05-12
• Study Start: 2015-07
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-02
• Last Update Posted: 2018-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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).

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telemetry	Telemetry	In this group, participants will have a prehospital 12 lead ECG taken and sent through to the receiving facility.
Non-Telemetry	Non-telemetry	In this group, participants will have a prehospital 12 lead ECG taken which will not be sent through to the receiving facility.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (2)

ER24 Western Cape Region; 🇿🇦 Cape Town, Western Cape, South Africa

ER24 Gauteng Region; 🇿🇦 Johannesburg, Gauteng, South Africa