The Effect of 12 Lead ECG Telemetry on Reperfusion Time in Resource-limited Settings
Primary Purpose
Myocardial Infarction, STEMI
Status
Completed
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
Telemetry
Non-telemetry
Sponsored by
About this trial
This is an interventional health services research trial for Myocardial Infarction
Eligibility Criteria
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
Sites / Locations
- ER24 Gauteng Region
- ER24 Western Cape Region
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Telemetry
Non-Telemetry
Arm Description
In this group, participants will have a prehospital 12 lead ECG taken and sent through to the receiving facility.
In this group, participants will have a prehospital 12 lead ECG taken which will not be sent through to the receiving facility.
Outcomes
Primary Outcome Measures
Reperfusion Time
This outcome measures the time it takes to reperfuse a coronary artery in STEMI
Secondary Outcome Measures
Prehospital Time
The prehospital time is the total time from arrival at the patient to arrival at the hospital
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
Full Information
NCT ID
NCT02441582
First Posted
May 5, 2015
Last Updated
March 2, 2018
Sponsor
Karolinska Institutet
Collaborators
ER24, University of Stellenbosch, Philips Healthcare
1. Study Identification
Unique Protocol Identification Number
NCT02441582
Brief Title
The Effect of 12 Lead ECG Telemetry on Reperfusion Time in Resource-limited Settings
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
ER24, University of Stellenbosch, Philips Healthcare
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, STEMI
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Telemetry
Arm Type
Experimental
Arm Description
In this group, participants will have a prehospital 12 lead ECG taken and sent through to the receiving facility.
Arm Title
Non-Telemetry
Arm Type
Other
Arm Description
In this group, participants will have a prehospital 12 lead ECG taken which will not be sent through to the receiving facility.
Intervention Type
Other
Intervention Name(s)
Telemetry
Intervention Type
Other
Intervention Name(s)
Non-telemetry
Primary Outcome Measure Information:
Title
Reperfusion Time
Description
This outcome measures the time it takes to reperfuse a coronary artery in STEMI
Time Frame
At the first moment of reperfusion, from the date of randomisation up to 14 days
Secondary Outcome Measure Information:
Title
Prehospital Time
Description
The prehospital time is the total time from arrival at the patient to arrival at the hospital
Time Frame
On arrival at hospital; from the time of randomisation up to six hours
Title
Onset to reperfusion time
Description
This pertains to the time it takes from the moment of first onset of symptoms to the first moment of reperfusion
Time Frame
At the first moment of reperfusion, from the date of randomisation up to 14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
ER24 Gauteng Region
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2110
Country
South Africa
Facility Name
ER24 Western Cape Region
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
8001
Country
South Africa
12. IPD Sharing Statement
Learn more about this trial
The Effect of 12 Lead ECG Telemetry on Reperfusion Time in Resource-limited Settings
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