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

Not Applicable

Recruiting

• Conditions: ST Elevation Myocardial Infarction; Electrocardiogram
• Interventions: Diagnostic Test: KardiaMobile 6L

• Registration Number: NCT05777083
• Lead Sponsor: Ewha Womans University Mokdong Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Study First Submitted: 2023-01-19
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-07
• Last Update Submitted: 2023-03-07
• Study First Posted: 2023-03-21
• Last Update Posted: 2023-03-21
• Primary Completion: 2023-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 216

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	KardiaMobile 6L	Patients who undergo elective coronary angiography to differentiate angina symptom. ST-elevation myocardial infarction will be excluded.
Inferior STEMI group	KardiaMobile 6L	Patients who undergo emergent coronary angiography for ST-elevation myocardial infarction.

Primary Outcome Measures

Name	Time	Method
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 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.
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 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 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).

Secondary Outcome Measures

Name	Time	Method
Angiographic results	during the procedure	Angiographic results of CAG reported by interventional cardiologist who performed CAG. Result is recorded as below; 1. Angiographical Disease Extent; * 1) normal 2) minimal 3) 1-vessel disease 4) 2-vessel disease 5) 3-vessel disease; 2. Left Main Disease : 1) Yes 2) No; 3. LAD involvement : 1) Yes 2) No; 4. LCX involvement : 1) Yes 2) No; 5. RCA involvement : 1) Yes 2) No; 6. PCI performing : 1) Yes 2) No; 7. Revascularization segment : 1) RCA 2) LAD 3) LCX 4) LM

Trial Locations

Locations (1)

Ewha womans university mokdong hospital; 🇰🇷 Yangcheon, Seoul, Korea, Republic of