Clinical trial of vagus nerve stimulation therapy in patients with acute ST-elevation myocardial infarction

JRCT ID: jRCT2052230039

Registered date:13/06/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: acute ST-elevation myocardial infarction
• Date of first enrollment: 13/06/2023
• Target sample size: 20
• Study type: Interventional

Intervention(s)

Transvenous vagus nerve stimulation using the investigational device
The investigational device will be implanted within the superior vena cava to deliver intermittent transvascular vagus nerve stimulation for 72 hours post-reperfusion.

Outcome(s)

Primary Outcome

Incidence of events, irrespective of whether or not they are related to the study device (from device placement to 1 day after removal)
<Event>
Fatal ventricular arrhythmias, ventricular pacing, severe hemorrhage, cardiac death, shock, stroke, complete atrioventricular block, and other fatal cardiovascular events

Secondary Outcome

Efficacy endpoint
(1) MRI (6 days, 12 weeks after placement of the study device)
Evaluation index: Infarction size, Myocardial salvage index, EF, left ventricle end-diastolic volume, ventricular weight
(2) Peak value and area under curve value of myocardial enzymes (CK-MB and troponin T)
(3, 6, 9, 12, 15, 18, 21, 24, 48, 72 hours after placement of the study device)
(3) Changes in echocardiography (left ventricular end-diastolic volume and EF) (8 days and 12 weeks after placement of the investigational device)
(4) Changes in BNP (8 days and 12 weeks after placement of the investigational device)
(5) Changes in heart rate before and during nerve stimulation

Safety endpoint
(1) Blood count/blood biochemistry test (GOT, LDH, BUN, Cre, Na, K, Cl, RBC, Hb, Ht, WBC, PLT) (1, 2, 3, 4, 8 days, 1 day after removal of the study device)
(2) D-dimer (1, 2, 3, 4 days after placement of the investigational device)
(3) Jugular vein echo (presence of thrombus, presence of stenosis/occlusion)
(4) Investigational device placement completion rate (completion: placement for 72 hours or longer)
(5) Adverse events (device placement to 7 days after removal)
Anticipated adverse events: cough, tracheal spasm, nausea, vomiting, diarrhea, symptomatic bradycardia, new atrial fibrillation, atrial arrhythmia (including pacing-induced), nonfatal ventricular arrhythmia, phrenic nerve stimulation , chest spasm, chest pain, hypotension, vascular injury, vascular stenosis, vascular perforation, infection, pulmonary embolism, hemorrhage, venous occlusion, pneumothorax, hemothorax, arterial puncture, air embolism, other serious cardiovascular events
(6) Malfunction of the investigational device

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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
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

Related Information

• Primary Sponsor: Noguchi Teruo
• Source(s) of Monetary Support: Adriakaim, Inc.