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

ST Elevation Myocardial Infarction Clinical Trial

— HINT-MI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05777083
• Other study ID #: HINT-MI
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: December 2024

Study information

• Verified date: March 2023
• Source: Ewha Womans University Mokdong Hospital
• Contact: In Sook Kang
• Phone: 82-10-9184-9338
• Email: pinkvision21[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 216
• Est. completion date: December 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Electrocardiogram
• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction

Intervention

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.).

Locations

Country	Name	City	State
Korea, Republic of	Ewha womans university mokdong hospital	Yangcheon	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Ewha Womans University Mokdong Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)
Primary	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
Primary	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)
Primary	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
Primary	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	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