JPRN-jRCT2052230039招募中1 期
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 个研究点目标入组 20 人开始时间: 2023年6月13日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •(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
排除标准
- •(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
- •Patients on maintenance dialysis
- •Use of implantable pacemakers, ICD, CRT, or CRT-D
- •(6) Patients with a heart rate of 50/min or less after PCI
- •(7) Patients with cardiac or vascular structures that make placement of the investigational device technically difficult
- •(8) Patients with malignant tumors
- •(9) Patients with uncontrolled inflammatory disease
- •(10) Diabetic patients taking insulin
- •(11) Pregnant women, lactating women, or patients who cannot consent to contraception during study participation
- •(12) Patients with contraindications to the use of investigational devices
- •(13) Patients contraindicated for anticoagulant therapy
- •(14) Patients with gastrointestinal, urinary, or central nervous system bleeding within the past 2 months
- •(15) Patients who have difficulty performing the tests required in this clinical trial (e.g. claustrophobia, MRI not possible due to eGFR less than 30, etc.)
- •(16) Patients scheduled for major surgery within 12 weeks after placement of the investigational device
- •(17) Patients whose follow-up for 12 weeks from the date of placement of the investigational device is presumed to be difficult
- •(18) Patients participating in other clinical trials or interventional studies at the time of eligibility determination
- •(19) Patients other than the above who are judged by the investigator to be inappropriate for participation in the clinical trial
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