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临床试验/NCT05777083
NCT05777083招募中不适用

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

Ewha Womans University Mokdong Hospital1 个研究点 分布在 1 个国家目标入组 216 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
216
试验地点
1
主要终点
Height (amplitude) of the ST segment of lead II, III and aVF at 6-leads ECG from monitoring equipment after CAG

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Height (amplitude) of the ST segment of lead II, III and aVF at 6-leads ECG from monitoring equipment after CAG

时间窗: 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 after CAG

时间窗: 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.

Height (amplitude) of the ST segment of lead II, III and aVF at portable 6-leads ECG from KardiaMobile 6L after CAG

时间窗: 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

时间窗: 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 Standard 12-lead ECG before CAG

时间窗: 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 portable 6-leads electrocardiography (ECG) from KardiaMobile 6L before coronary angiography (CAG)

时间窗: 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).

次要结局

  • Angiographic results(during the procedure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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