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The goal of this clinical trial is to compare the result from the a six-leads handheld electrocardiogram (ECG) recorder (KardiaMobile 6L) with those of the standard 12-leads ECG at the patients of acute inferior wall ST-elevation myocardial infarction (STEMI), then ultimately reduce the time it takes to perform re-through treatment according to the faster diagnosis.
Participants with STEMI who visited the emergency room will be recorded 6-leads ECG using KardiaMobile 6L in addition to the standard 12-lads ECG, which is basically performed for all patients of acute coronary syndrome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inferior STEMI group | Experimental | Patients who undergo emergent coronary angiography for ST-elevation myocardial infarction. |
|
| Control group | Active Comparator | Patients who undergo elective coronary angiography to differentiate angina symptom. ST-elevation myocardial infarction will be excluded. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KardiaMobile 6L | Diagnostic Test | Before coronary angiography, all participants will contact both fingers on the two probes at the front side of portable 6-leads electrocardiogram recorder (KardiaMobile 6L), and be recorded all six leads by contacting the other side of probe at lower extremities (left hip bone ridge, thigh, knee, lower abdomen, etc.). |
| Measure | Description | Time Frame |
|---|---|---|
| Height (amplitude) of the ST segment of lead II, III and aVF at portable 6-leads electrocardiography (ECG) from KardiaMobile 6L before coronary angiography (CAG) | Height (amplitude) of the ST segment of lead II, III and aVF at portable 6-leads ECG obtained using KardiaMobile 6L between the ER visit and performing emergent CAG (experimental group) or between the admission and elective CAG (control group). | pre-intervention |
| Height (amplitude) of the ST segment of lead II, III and aVF at portable 6-leads ECG from KardiaMobile 6L after CAG | Height (amplitude) of the ST segment of lead II, III and aVF at portable 6-leads ECG obtained using KardiaMobile 6L within 30 minutes of the end of the CAG. | immediately after the intervention (within 30 minutes) |
| Height (amplitude) of the ST segment of lead II, III and aVF at 6-leads ECG from monitoring equipment before CAG | Height (amplitude) of the ST segment of lead II, III and aVF at 6-leads ECG obtained from monitoring equipment at angiographic room between the time of ER visit and performing emergent CAG (experimental group) or between the admission and performing elective CAG (control group). | pre-intervention |
| Height (amplitude) of the ST segment of lead II, III and aVF at 6-leads ECG from monitoring equipment after CAG | Height (amplitude) of the ST segment of lead II, III and aVF at 6-leads ECG obtained from monitoring equipment at angiographic room within 30 minutes of the end of the CAG. | immediately after the intervention (within 30 minutes) |
| Height (amplitude) of the ST segment of lead II, III and aVF at Standard 12-lead ECG before CAG | Height (amplitude) of the ST segment of lead II, III and aVF at Standard 12 lead ECG which is taken between the time of ER visit and performing emergent CAG (experimental group) or between the admission and performing elective CAG (control group). |
| Measure | Description | Time Frame |
|---|---|---|
| Angiographic results | Angiographic results of CAG reported by interventional cardiologist who performed CAG. Result is recorded as below;
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| In Sook Kang | Contact | 82-10-9184-9338 | pinkvision21@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| In Sook Kang | Ewha Womans University Mokdong Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ewha womans university mokdong hospital | Recruiting | Yangcheon | Seoul | 07985 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29493801 | Background | Narasimha D, Hanna N, Beck H, Chaskes M, Glover R, Gatewood R, Bourji M, Gudleski GD, Danzer S, Curtis AB. Validation of a smartphone-based event recorder for arrhythmia detection. Pacing Clin Electrophysiol. 2018 May;41(5):487-494. doi: 10.1111/pace.13317. Epub 2018 Apr 15. | |
| 34288227 | Background | Kleiman R, Darpo B, Brown R, Rudo T, Chamoun S, Albert DE, Bos JM, Ackerman MJ. Comparison of electrocardiograms (ECG) waveforms and centralized ECG measurements between a simple 6-lead mobile ECG device and a standard 12-lead ECG. Ann Noninvasive Electrocardiol. 2021 Nov;26(6):e12872. doi: 10.1111/anec.12872. Epub 2021 Jul 19. |
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| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
| pre-intervention |
| Height (amplitude) of the ST segment of lead II, III and aVF at Standard 12-lead ECG after CAG | Height (amplitude) of the ST segment of lead II, III and aVF at Standard 12 lead ECG which is taken within 30 minutes of the end of the CAG. | immediately after the intervention (within 30 minutes) |
| during the procedure |
| 33099175 | Background | Mercer B, Leese L, Ahmed N, Holden AV, Tayebjee MH. A simple adaptation of a handheld ECG recorder to obtain chest lead equivalents. J Electrocardiol. 2020 Nov-Dec;63:54-56. doi: 10.1016/j.jelectrocard.2020.10.005. Epub 2020 Oct 16. |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |