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

Myocardial Infarction Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02441582
• Other study ID #: 3-1178/2014
• Status: Completed
• Phase: N/A
• First received: May 5, 2015
• Last updated: March 2, 2018
• Start date: July 2015
• Est. completion date: October 2017

Study information

• Verified date: March 2018
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• STEMI

Intervention

Other:
• Telemetry

• Non-telemetry

Locations

Country	Name	City	State
South Africa	ER24 Western Cape Region	Cape Town	Western Cape
South Africa	ER24 Gauteng Region	Johannesburg	Gauteng

Sponsors (4)

Lead Sponsor	Collaborator
Karolinska Institutet	ER24, Philips Healthcare, University of Stellenbosch

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Prehospital Time	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
Secondary	Onset to reperfusion time	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