NCT05777083

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
216

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

January 19, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 21, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

March 21, 2023

Status Verified

March 1, 2023

Enrollment Period

11 months

First QC Date

January 19, 2023

Last Update Submit

March 7, 2023

Conditions

ST Elevation Myocardial InfarctionElectrocardiogram

Keywords

Kardiamobile 6L

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (1)

  • Angiographic results

    during the procedure

Study Arms (2)

Inferior STEMI group

EXPERIMENTAL

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

Diagnostic Test: KardiaMobile 6L

Control group

ACTIVE COMPARATOR

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

Diagnostic Test: KardiaMobile 6L

Interventions

KardiaMobile 6LDIAGNOSTIC_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 groupInferior STEMI group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ewha womans university mokdong hospital

Yangcheon, Seoul, 07985, South Korea

RECRUITING

Related Publications (3)

  • 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.

    PMID: 29493801BACKGROUND

  • 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.

    PMID: 34288227BACKGROUND

  • 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.

    PMID: 33099175BACKGROUND

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • In Sook Kang

    Ewha Womans University Mokdong Hospital

    STUDY CHAIR

Central Study Contacts

In Sook Kang

CONTACT

82-10-9184-9338pinkvision21@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2023

First Posted

March 21, 2023

Study Start

January 1, 2023

Primary Completion

December 1, 2023

Study Completion

December 1, 2024

Last Updated

March 21, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)