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

NCT02441582 | Completed

• 1 other identifier: 3-1178/2014
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 2

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.

Conditions

Myocardial Infarction; STEMI

Outcome Measures

Primary Outcomes (1)

• Reperfusion Time

  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 Outcomes (2)

• Prehospital Time

  On arrival at hospital; from the time of randomisation up to six hours

• Onset to reperfusion time

  At the first moment of reperfusion, from the date of randomisation up to 14 days

Study Arms (2)

Telemetry

EXPERIMENTAL

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

Other: Telemetry

Non-Telemetry

OTHER

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

Interventions

Telemetry OTHER

Telemetry

Non-telemetry OTHER

Non-Telemetry

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Non-adult patients
• Chest pain of non-cardiac aetiology (following trauma or due to a primary respiratory pathology)
• Patients without medical aid or who states that they cannot afford private healthcare.
• Non-ST-elevation myocardial infarction

Sponsors & Collaborators

• Karolinska Institutet: lead
• ER24: collaborator
• University of Stellenbosch: collaborator
• Philips Healthcare: collaborator

Study Sites (2)

ER24 Gauteng Region

Johannesburg, Gauteng, 2110, South Africa

Location

ER24 Western Cape Region

Cape Town, Western Cape, 8001, South Africa

Location

MeSH Terms

Conditions

Myocardial Infarction; ST Elevation Myocardial Infarction

Interventions

Telemetry

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 5, 2015
• First Posted: May 12, 2015
• Study Start: July 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: March 5, 2018

Record last verified: 2018-03

Locations

ZA (2)