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

Primary Purpose

ST Elevation Myocardial Infarction, Electrocardiogram

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
KardiaMobile 6L
Sponsored by
Ewha Womans University Mokdong Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for ST Elevation Myocardial Infarction focused on measuring Kardiamobile 6L

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ewha womans university mokdong hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Inferior STEMI group

Control group

Arm Description

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

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

Outcomes

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)
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
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
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
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
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
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
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

Full Information

First Posted
January 19, 2023
Last Updated
March 7, 2023
Sponsor
Ewha Womans University Mokdong Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05777083
Brief Title
A Trial for the Earlier Diagnosis of Inferior Wall STEMI Using a Six-lead Handheld EKG Recorder
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ewha Womans University Mokdong Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST Elevation Myocardial Infarction, Electrocardiogram
Keywords
Kardiamobile 6L

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
216 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Inferior STEMI group
Arm Type
Experimental
Arm Description
Patients who undergo emergent coronary angiography for ST-elevation myocardial infarction.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Patients who undergo elective coronary angiography to differentiate angina symptom. ST-elevation myocardial infarction will be excluded.
Intervention Type
Diagnostic Test
Intervention Name(s)
KardiaMobile 6L
Intervention Description
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.).
Primary Outcome Measure Information:
Title
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)
Description
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).
Time Frame
pre-intervention
Title
Height (amplitude) of the ST segment of lead II, III and aVF at portable 6-leads ECG from KardiaMobile 6L after CAG
Description
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.
Time Frame
immediately after the intervention (within 30 minutes)
Title
Height (amplitude) of the ST segment of lead II, III and aVF at 6-leads ECG from monitoring equipment before CAG
Description
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).
Time Frame
pre-intervention
Title
Height (amplitude) of the ST segment of lead II, III and aVF at 6-leads ECG from monitoring equipment after CAG
Description
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.
Time Frame
immediately after the intervention (within 30 minutes)
Title
Height (amplitude) of the ST segment of lead II, III and aVF at Standard 12-lead ECG before CAG
Description
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).
Time Frame
pre-intervention
Title
Height (amplitude) of the ST segment of lead II, III and aVF at Standard 12-lead ECG after CAG
Description
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.
Time Frame
immediately after the intervention (within 30 minutes)
Secondary Outcome Measure Information:
Title
Angiographic results
Description
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
Time Frame
during the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
In Sook Kang
Phone
82-10-9184-9338
Email
pinkvision21@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
In Sook Kang
Organizational Affiliation
Ewha Womans University Mokdong Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Ewha womans university mokdong hospital
City
Yangcheon
State/Province
Seoul
ZIP/Postal Code
07985
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jungeun Yoon
Phone
82-2-2650-5083
Email
cardionephrocrc@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29493801
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.
Results Reference
background
PubMed Identifier
34288227
Citation
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.
Results Reference
background
PubMed Identifier
33099175
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.
Results Reference
background

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

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