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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05777083

Acronym

HINT-MI

Enrollment

216

Registered

2023-03-21

Start date

2023-01-01

Completion date

2024-12-31

Last updated

2023-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Electrocardiogram, ST Elevation Myocardial Infarction

Keywords

Kardiamobile 6L

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.

Interventions

DIAGNOSTIC_TESTKardiaMobile 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.).

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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).
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 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 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 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.

Secondary

Measure	Time frame	Description
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

Countries

South Korea

Contacts

Primary ContactIn Sook Kang

pinkvision21@gmail.com82-10-9184-9338

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026