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

NCT ID: NCT02441582

Last Updated: 2018-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2017-10-31

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.

Detailed Description

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Conditions

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Myocardial Infarction STEMI

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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Telemetry

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

Group Type EXPERIMENTAL

Telemetry

Intervention Type OTHER

Non-Telemetry

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

Group Type OTHER

Non-telemetry

Intervention Type OTHER

Interventions

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Telemetry

Intervention Type OTHER

Non-telemetry

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ER24

UNKNOWN

Sponsor Role collaborator

University of Stellenbosch

OTHER

Sponsor Role collaborator

Philips Healthcare

INDUSTRY

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Willem Stassen

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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ER24 Gauteng Region

Johannesburg, Gauteng, South Africa

Site Status

ER24 Western Cape Region

Cape Town, Western Cape, South Africa

Site Status

Countries

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South Africa

Other Identifiers

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3-1178/2014

Identifier Type: -

Identifier Source: org_study_id

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