Chest PainNCT04048733
Timely Acquirement of 12-lead ECG Using Patchy-type Wireless Device Among Patient With Chest Pain
A study testing patchy-type wireless 12-lead ECG in people with Chest Pain and Electrocardiography, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
In this study, the investigators compare timely acquirement of 12-lead ECG using patchy-type wireless versus using standard 12-lead ECG system among patient with chest pain in ED. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chest Pain, Electrocardiography
- What is being tested?
- patchy-type wireless 12-lead ECG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Jul 2019to 16 Dec 2019
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A subject who visited the ER with a cardiogenic chest pain
- adult patients over 19 years of age
- A subject who completed the 1st ECG
Who cannot join
- A subject who did not agree with this study
- arrest patient
- Dead on arrival
- STEMI patients who confirmed by 1st ECG in ER
- shock status patient in triage state
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Timely Acquirement of 12-lead Electrocardiography Using Patchy-type Wireless Device Among Patient With Chest Pain in Emergency Departement
In this study, the investigators compare timely acquirement of 12-lead ECG using patchy-type wireless versus using standard 12-lead ECG system among patient with chest pain in ED. The purpose of this study is to determine the difference of timely acquirement of 12-lead ECG using two different systems and the difference of hospital delay in ED between two groups. The participants were randomly divided into 2 groups: one performing an ECG examination using the standard 12-lead ECG and the other using the patch-type mobile 12-lead ECG.The 12-lead ECG will be taken 2 times serially in every 15 minutes.
Read the detailed description
- research background Electrocardiography (ECG) is the most important diagnostic tool for rapid detection of acute coronary syndrome, and should be performed and interpreted promptly on appearance of symptoms. Early detection of ST-elevation myocardial infarction (STEMI) on a 12-lead ECG, within 10 minutes after the first medical contact before hospitalization not only minimizes the time taken for diagnosis and reperfusion therapy but also increases the chances of patient survival and preservation of myocardial function. However, it is challenging to perform a 12-lead ECG promptly using the standard 12-lead ECG system for several reasons. First, it is difficult to identify the landmarks for the 10-electrode configuration of the standard ECG. Second, electrodes on the extremities often cause artifacts due to body and muscle movements. Moreover, most of the standard 12-lead ECG systems have cables connected to the precordial and limb leads, which frequently get entangled and disorganized, and can be difficult to manage.Most importantly, its accuracy is dependent on the operators' experience; not just that of the nurses or emergency medical technicians, but also of cardiologists.These difficulties might increase the time taken to perform an ECG especially in pre-hospital situations.
- Objective The purpose of this study is to determine the difference of timely acquirement of 12-lead ECG using two different systems and the difference of hospital delay in ED between two groups.
- Design : Randomized controlled trial
- Setting : ED at the Samsung medical center
- Enrollment : 36 patients who visited the ED with chest pain
- Intervention Standard 12-lead ECG will be performed at the time of visiting ED to the participants with chest pain.
ED physicians will prescribe to perform second and third 12-lead ECG in every 15 minutes.
- Control group : Second and third 12 lead ECG will be taken using standard 12-lead ECG device as a doctor's order.
- Study group :Second and third 12 lead ECG will be taken using patchy-type 12-lead ECG device as a doctor's order.
- scoring To measure, interval from the anticipated time to take 12-lead ECG to the time actually performed will be measured. The duration from the anticipated time to the time of verification by physician will be also measured.
- study period The experiment ends when patient who agreed to participate in the study discharged the ED.
- Conditions
- Chest Pain, Electrocardiography
- Being tested
- patchy-type wireless 12-lead ECG
- Keywords
- Electrocardiography, Chest pain, Emergency Service,Hospital, Wireless Technology
- Medical subject headings
- Chest Pain, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patchy-type wireless 12-lead ECGDevice
Perform 12-lead ECG using patchy-type wireless 12-lead ECG. This device automatically record 12-lead ECG in every 15 minutes by its algorithm.
| Study group | Role | What they receive |
|---|---|---|
| Patchy type-lead ECG | Experimental | ED physicians will prescribe to perform second and third 12-lead ECG in every 15 minutes.
Second and third 12 lead ECG will be taken using patchy-type 12-lead ECG device as a doctor's order. This device will be automatically record 12-lead ECG 3 times in 1 minutes at a time by its algorithm. Receives: Device: patchy-type wireless 12-lead ECG |
| Standard 12-lead ECG | No intervention | ED physicians will prescribe to perform second and third 12-lead ECG in every 15 minutes. Second and third 12 lead ECG will be taken using standard 12-lead ECG device as a doctor's order. Interns and ECG technicians will perform 12-lead ECG as they perform as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from ordering to performing 12-lead ECGs during up to 24 hours in ED.
Comparison of interval from the anticipated time to take 12-lead ECG to the time actually performed will be measured.
Measured: measure the time duration from ECG ordering to performing during up to 24 hours in ED
Time from ordering to verifying 12-lead ECGs by ED physician during up to 24 hours in ED.
Comparison of interval from the anticipated time to take 12-lead ECG to the time verified by physician
Measured: measure the time duration from ECG ordering to verifying by ED physician during up to 24 hours in ED
Secondary outcomes (1)
The Presence of artifacts in 12-lead ECGs.
Comparison of the presence of artifacts in 12-lead ECGs in intervention group and control group
Measured: ECG reading and checking of presence of artifacts in 12 lead ECGs through study completion, an average of 1 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study start30 Jul 2019
- Primary completion8 Oct 2019
- Study completion16 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest PainStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- wonchul cha, doctoral, Principal investigator, samsumg medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04048733
- Sponsor's protocol ID
- 2019-01-046
- Status last verified
- Oct 2020
- First submitted
- 31 Jul 2019
- Last updated
- 23 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timely Acquirement of 12-lead Electrocardiography Using Patchy-type Wireless Device Among Patient With Chest Pain in Emergency Departement
- ClinicalTrials.gov ID
- NCT04048733
- Acronym / sponsor ID
- 2019-01-046
- Conditions
- Chest Pain, Electrocardiography
- Keywords
- Electrocardiography, Chest pain, Emergency Service,Hospital, Wireless Technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 30 Jul 2019 (actual)
- Primary completion
- 8 Oct 2019 (actual)
- Study completion
- 16 Dec 2019 (actual)
- First posted
- 7 Aug 2019 (actual)
- 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.
In this study, the investigators compare timely acquirement of 12-lead ECG using patchy-type wireless versus using standard 12-lead ECG system among patient with chest pain in ED. The purpose of this study is to determine the difference of timely acquirement of 12-lead ECG using two different systems and the difference of hospital delay in ED between two groups. The participants were randomly divided into 2 groups: one performing an ECG examination using the standard 12-lead ECG and the other using the patch-type mobile 12-lead ECG.The 12-lead ECG will be taken 2 times serially in every 15 minutes.
Detailed description
- research background Electrocardiography (ECG) is the most important diagnostic tool for rapid detection of acute coronary syndrome, and should be performed and interpreted promptly on appearance of symptoms. Early detection of ST-elevation myocardial infarction (STEMI) on a 12-lead ECG, within 10 minutes after the first medical contact before hospitalization not only minimizes the time taken for diagnosis and reperfusion therapy but also increases the chances of patient survival and preservation of myocardial function. However, it is challenging to perform a 12-lead ECG promptly using the standard 12-lead ECG system for several reasons. First, it is difficult to identify the landmarks for the 10-electrode configuration of the standard ECG. Second, electrodes on the extremities often cause artifacts due to body and muscle movements. Moreover, most of the standard 12-lead ECG systems have cables connected to the precordial and limb leads, which frequently get entangled and disorganized, and can be difficult to manage.Most importantly, its accuracy is dependent on the operators' experience; not just that of the nurses or emergency medical technicians, but also of cardiologists.These difficulties might increase the time taken to perform an ECG especially in pre-hospital situations.
- Objective The purpose of this study is to determine the difference of timely acquirement of 12-lead ECG using two different systems and the difference of hospital delay in ED between two groups.
- Design : Randomized controlled trial
- Setting : ED at the Samsung medical center
- Enrollment : 36 patients who visited the ED with chest pain
- Intervention Standard 12-lead ECG will be performed at the time of visiting ED to the participants with chest pain.
ED physicians will prescribe to perform second and third 12-lead ECG in every 15 minutes.
- Control group : Second and third 12 lead ECG will be taken using standard 12-lead ECG device as a doctor's order.
- Study group :Second and third 12 lead ECG will be taken using patchy-type 12-lead ECG device as a doctor's order.
- scoring To measure, interval from the anticipated time to take 12-lead ECG to the time actually performed will be measured. The duration from the anticipated time to the time of verification by physician will be also measured.
- study period The experiment ends when patient who agreed to participate in the study discharged the ED.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patchy type-lead ECG | Experimental | Device: patchy-type wireless 12-lead ECGED physicians will prescribe to perform second and third 12-lead ECG in every 15 minutes. Second and third 12 lead ECG will be taken using patchy-type 12-lead ECG device as a doctor's order. This device will be automatically record 12-lead ECG 3 times in 1 minutes at a time by its algorithm. |
| Standard 12-lead ECG | No intervention | –ED physicians will prescribe to perform second and third 12-lead ECG in every 15 minutes. Second and third 12 lead ECG will be taken using standard 12-lead ECG device as a doctor's order. Interns and ECG technicians will perform 12-lead ECG as they perform as usual. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A subject who visited the ER with a cardiogenic chest pain
- adult patients over 19 years of age
- A subject who completed the 1st ECG
Key exclusion criteria (5 listed)
- A subject who did not agree with this study
- arrest patient
- Dead on arrival
- STEMI patients who confirmed by 1st ECG in ER
- shock status patient in triage state
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 |
|---|---|---|
| patchy-type wireless 12-lead ECGPerform 12-lead ECG using patchy-type wireless 12-lead ECG. This device automatically record 12-lead ECG in every 15 minutes by its algorithm. | Device | Patchy type-lead ECG |
Primary outcome
Time from ordering to performing 12-lead ECGs during up to 24 hours in ED.
Time frame: measure the time duration from ECG ordering to performing during up to 24 hours in ED
Comparison of interval from the anticipated time to take 12-lead ECG to the time actually performed will be measured.
Time from ordering to verifying 12-lead ECGs by ED physician during up to 24 hours in ED.
Time frame: measure the time duration from ECG ordering to verifying by ED physician during up to 24 hours in ED
Comparison of interval from the anticipated time to take 12-lead ECG to the time verified by physician
1 secondary outcome
The Presence of artifacts in 12-lead ECGs.
Time frame: ECG reading and checking of presence of artifacts in 12 lead ECGs through study completion, an average of 1 month.
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 23 Oct 2020.
- Individual participant dataSharing planned: No
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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.
wonchul cha, doctoral principal investigator
samsumg medical center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing patchy-type wireless 12-lead ECG in people with Chest Pain and Electrocardiography, run by Samsung Medical Center at 1 site in South Korea.
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 3 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 23 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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?
Time from ordering to performing 12-lead ECGs during up to 24 hours in ED. (time frame: measure the time duration from ECG ordering to performing during up to 24 hours in ED). The study lists 2 primary outcomes in all. 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 23 Oct 2020.