A Trial for the Earlier Diagnosis of Inferior Wall STEMI Using a Six-lead Handheld EKG Recorder

Study Overview
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Brief Summary
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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.

Official Title
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A Trial for the Possibility of Earlier Diagnosis of Inferior Wall ST-elevation Myocardial Infarction Using a Six-lead Handheld EKG Recorder (Kardiamobile 6L)

Conditions
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ST Elevation Myocardial Infarction, Electrocardiogram

Intervention / Treatment
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* Diagnostic Test: KardiaMobile 6L


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Among the patients over 19-year-old, patients of ST-elevation myocardial infarction who visit the emergency room and perform emergency coronary angiography or Among the patients over 19-year-old, patients who visit outpatient clinics and perform elective coronary angiography for evaluating chest pain Exclusion Criteria: Patients with severe complications of myocardial infarction; cardiogenic shock, respiratory failure and mental change Patients who are unable to agree or disagree a written consent

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inferior STEMI group<br>Patients who undergo emergent coronary angiography for ST-elevation myocardial infarction. | Diagnostic Test: KardiaMobile 6L<br>* 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.).<br>|
| Active Comparator: Control group<br>Patients who undergo elective coronary angiography to differentiate angina symptom. ST-elevation myocardial infarction will be excluded. | Diagnostic Test: KardiaMobile 6L<br>* 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.).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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). | 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Angiographic results | Angiographic results of CAG reported by interventional cardiologist who performed CAG. Result is recorded as below; Angiographical Disease Extent 1) normal 2) minimal 3) 1-vessel disease 4) 2-vessel disease 5) 3-vessel disease Left Main Disease : 1) Yes 2) No LAD involvement : 1) Yes 2) No LCX involvement : 1) Yes 2) No RCA involvement : 1) Yes 2) No PCI performing : 1) Yes 2) No Revascularization segment : 1) RCA 2) LAD 3) LCX 4) LM | during the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kardiamobile 6L