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

NCT ID: NCT05777083

Last Updated: 2023-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2024-12-31

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.

Detailed Description

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Conditions

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ST Elevation Myocardial Infarction Electrocardiogram

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Inferior STEMI group

Patients who undergo emergent coronary angiography for ST-elevation myocardial infarction.

Group Type EXPERIMENTAL

KardiaMobile 6L

Intervention Type 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.).

Control group

Patients who undergo elective coronary angiography to differentiate angina symptom. ST-elevation myocardial infarction will be excluded.

Group Type ACTIVE_COMPARATOR

KardiaMobile 6L

Intervention Type 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.).

Interventions

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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.).

Intervention Type DIAGNOSTIC_TEST

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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ewha Womans University Mokdong Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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In Sook Kang

Role: STUDY_CHAIR

Ewha Womans University Mokdong Hospital

Locations

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Ewha womans university mokdong hospital

Yangcheon, Seoul, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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In Sook Kang

Role: CONTACT

82-10-9184-9338

Facility Contacts

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Jungeun Yoon

Role: primary

82-2-2650-5083

References

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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.

Reference Type BACKGROUND
PMID: 29493801 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34288227 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33099175 (View on PubMed)

Other Identifiers

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HINT-MI

Identifier Type: -

Identifier Source: org_study_id

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