HINT-MI: A Trial for the Earlier Diagnosis of Inferior Wall STEMI Using a Six-lead Handheld EKG Recorder
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Inferior STEMI group Patients who undergo emergent coronary angiography for ST-elevation myocardial infarction. |
Diagnostic Test: KardiaMobile 6L
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.).
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| Active Comparator: Control group Patients who undergo elective coronary angiography to differentiate angina symptom. ST-elevation myocardial infarction will be excluded. |
Diagnostic Test: KardiaMobile 6L
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.).
|
Outcome Measures
Primary Outcome Measures
- 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) [pre-intervention]
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).
- Height (amplitude) of the ST segment of lead II, III and aVF at portable 6-leads ECG from KardiaMobile 6L after CAG [immediately after the intervention (within 30 minutes)]
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.
- Height (amplitude) of the ST segment of lead II, III and aVF at 6-leads ECG from monitoring equipment before CAG [pre-intervention]
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).
- Height (amplitude) of the ST segment of lead II, III and aVF at 6-leads ECG from monitoring equipment after CAG [immediately after the intervention (within 30 minutes)]
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.
- Height (amplitude) of the ST segment of lead II, III and aVF at Standard 12-lead ECG before CAG [pre-intervention]
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).
- Height (amplitude) of the ST segment of lead II, III and aVF at Standard 12-lead ECG after 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 which is taken within 30 minutes of the end of the CAG.
Secondary Outcome Measures
- Angiographic results [during the procedure]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Among the patients over 19-year-old, patients of ST-elevation myocardial infarction who visit the emergency room and perform emergency coronary angiography or
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Among the patients over 19-year-old, patients who visit outpatient clinics and perform elective coronary angiography for evaluating chest pain
Exclusion Criteria:
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Patients with severe complications of myocardial infarction; cardiogenic shock, respiratory failure and mental change
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Patients who are unable to agree or disagree a written consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ewha womans university mokdong hospital | Yangcheon | Seoul | Korea, Republic of | 07985 |
Sponsors and Collaborators
- Ewha Womans University Mokdong Hospital
Investigators
- Study Chair: In Sook Kang, Ewha Womans University Mokdong Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- HINT-MI