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

Ewha Womans University

Status: Enrolling

Conditions: Electrocardiogram; ST Elevation Myocardial Infarction

Treatments: Diagnostic Test: KardiaMobile 6L

Study type: Interventional

Funder types: Other

Identifiers

NCT05777083

HINT-MI

Details and patient eligibility

About

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.

Enrollment: 216 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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216 participants in 2 patient groups

Inferior STEMI group

Experimental group

Description:

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

Treatment:

Diagnostic Test: KardiaMobile 6L

Control group

Active Comparator group

Description:

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

Treatment:

Diagnostic Test: KardiaMobile 6L