Myocardial InfarctionNCT02441582
The Effect of 12 Lead ECG Telemetry on Reperfusion Time in Resource-limited Settings
A study testing Telemetry and Non-telemetry in people with Myocardial Infarction and STEMI, run by Karolinska Institutet at 2 sites in South Africa.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, STEMI
- What is being tested?
- Telemetry and Non-telemetry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 2 sitesSouth Africa
- Study dates
- Jul 2015to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
South Africa2 sites
ER24 Western Cape Region
Cape Town, Western Cape, 8001
ER24 Gauteng Region
Johannesburg, Gauteng, 2110
About this study
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
- Being tested
- Telemetry, Non-telemetry
- Medical subject headings
- Myocardial Infarction, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelemetryOther
Non-telemetryOther
| Study group | Role | What they receive |
|---|---|---|
| Telemetry | Experimental | In this group, participants will have a prehospital 12 lead ECG taken and sent through to the receiving facility. Receives: 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. Receives: Other: Non-telemetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reperfusion Time
This outcome measures the time it takes to reperfuse a coronary artery in STEMI
Measured: At the first moment of reperfusion, from the date of randomisation up to 14 days
Secondary outcomes (2)
Prehospital Time
The prehospital time is the total time from arrival at the patient to arrival at the hospital
Measured: On arrival at hospital; from the time of randomisation up to six hours
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
Measured: At the first moment of reperfusion, from the date of randomisation up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startJul 2015
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- ER24, University of Stellenbosch, Philips Healthcare
- Responsible party
- Principal investigator, Willem Stassen, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02441582
- Sponsor's protocol ID
- 3-1178/2014
- Status last verified
- Mar 2018
- First submitted
- 5 May 2015
- Last updated
- 5 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of 12 Lead ECG Telemetry on Reperfusion Time in Resource-limited Settings
- ClinicalTrials.gov ID
- NCT02441582
- Acronym / sponsor ID
- 3-1178/2014
- Conditions
- Myocardial Infarction, STEMI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- ER24, University of Stellenbosch, Philips Healthcare
- Study start
- Jul 2015
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 12 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemetry | Experimental | Other: TelemetryIn this group, participants will have a prehospital 12 lead ECG taken and sent through to the receiving facility. |
| Non-Telemetry | Other | Other: Non-telemetryIn this group, participants will have a prehospital 12 lead ECG taken which will not be sent through to the receiving facility. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telemetry | Other | Telemetry |
| Non-telemetry | Other | Non-Telemetry |
Primary outcome
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
2 secondary outcomes
Prehospital Time
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemetry and Non-telemetry in people with Myocardial Infarction and STEMI, run by Karolinska Institutet at 2 sites in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reperfusion Time (time frame: At the first moment of reperfusion, from the date of randomisation up to 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2018.