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Completed

NCT Number: NCT02441582

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

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.

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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction STEMI Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ER24 Gauteng Region, Johannesburg, Gauteng, South Africa

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telemetry

Other

Non-telemetry

Other

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • ER24
  • Philips Healthcare
  • University of Stellenbosch

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 12, 2015
Registry last updated
Mar 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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