JPRN-jRCT2052230039
Recruiting
Phase 1
Phase I/II clinical trial to explore the safety and efficacy of vagus nerve stimulation therapy using the ARIS system in patients with acute ST-elevation myocardial infarction
oguchi Teruo0 sites20 target enrollmentJune 13, 2023
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- acute ST-elevation myocardial infarction
- Sponsor
- oguchi Teruo
- Enrollment
- 20
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(1\) Patients diagnosed with first ST elevation acute myocardial infarction
- •(2\) Patients diagnosed as follows
- •1st course: Class I of the Killip classification
- •2nd course: Class II/III of the Killip classification
- •3rd Course: Classes I to III of the Killip Classification
- •(3\) Patients who underwent PCI treatment for acute myocardial infarction and had reperfusion
- •(4\) Patients within 6 hours from the appearance of symptoms suggesting onset (chest pain, etc.) to reperfusion
- •(5\) Patients with TIMI flow of 0 or 1 in the culprit coronary artery on the first coronary angiography before PCI
- •(6\) Patients aged 18 years or older at the time of eligibility determination
- •(7\) Patients who have obtained written consent from the patient himself or his legal representative
Exclusion Criteria
- •(1\) Patients with cardiac arrest or cardiogenic shock due to myocardial infarction
- •(2\) Patients with right ventricular infarction
- •(3\) Patients with the left main trunk or two or more coronary arteries responsible
- •(4\) Patients with myocardial infarction due to coronary spasm
- •(5\) Patients with a history or comorbidity of any of the following
- •Unstable angina before myocardial infarction
- •History of coronary artery bypass graft (CABG)
- •History of cardiomyopathy
- •History of Brugada syndrome
- •Atrioventricular block greater than degree II
Outcomes
Primary Outcomes
Not specified
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