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

March 2, 2018 updated by: Willem Stassen, Karolinska Institutet
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2110
        • ER24 Gauteng Region
    • Western Cape
      • Cape Town, Western Cape, South Africa, 8001
        • ER24 Western Cape Region

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telemetry
In this group, participants will have a prehospital 12 lead ECG taken and sent through to the receiving facility.
Other: Telemetry
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.
Other: Non-telemetry

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reperfusion Time
Time Frame: 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
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
Time Frame: 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
On arrival at hospital; from the time of randomisation up to six hours
Onset to reperfusion time
Time Frame: 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
At the first moment of reperfusion, from the date of randomisation up to 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Collaborators

Philips Healthcare
University of Stellenbosch
ER24

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

May 5, 2015

First Submitted That Met QC Criteria

May 7, 2015

First Posted (Estimate)

May 12, 2015

Study Record Updates

Last Update Posted (Actual)

March 5, 2018

Last Update Submitted That Met QC Criteria

March 2, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3-1178/2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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