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A clinical study of transcutaneous auricular vagus nerve stimulation in alleviating depression levels in patients with acute coronary syndromesafter PCI

A clinical study of transcutaneous auricular vagus nerve stimulation in alleviating depression levels in patients with acute coronary syndromesafter PCI

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500096137
Enrollment
Unknown
Registered
2025-01-17
Start date
2024-07-05
Completion date
Unknown
Last updated
2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative depression after PCI in patients with acute coronary syndromes

Interventions

Experimental group:Patients who met the criteria for natriuresis were given percutaneous ear noninvasive vagus nerve stimulation in the awake state, firstly, the electrodes and the target area of the

Sponsors

The Second Affiliated Hospital of Air Force Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Age =18 years; 2) Meet the diagnostic criteria for ACS; 3) Vital signs were stable 14 days-12 months after successful PCI; 4) Meet the diagnostic criteria for depression in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V); 5) HAMD-17 scores of =7 and < lt;24, and HAMA scores < lt; HAMD scores; 6) After being fully informed of their condition, the patients or their clients refused topsychiatric consultation and refused to receive treatment such as antidepressant drugs or psychotherapy; 7) Patients or clients voluntarily participated in this study and signed an informed consent form.

Exclusion criteria

Exclusion criteria: 1) Severe heart failure (NYHA classification = Class III); 2) Uncontrolled hypertension (= 180/110 mmHg); 3) One degree of atrioventricular block (PR interval = 0.20s) on waking ECG or second or third degree atrioventricular block at any one time; 4) Mean heart rate = 50 beats/minute in 24 hours, RR interval = 3s or history of syncope not related to thehistory of syncope not related to the current ACS; 5) Dialysis patients; 6) Previous renal artery sympathetic ganglion ablation therapy or vagal node ablation therapy; 7) Life expectancy of less than 4 months; 8) Clinical diagnosis of severe other psychiatric disorders prior to PCI, including schizophrenia, severe intellectual disability, and substance abuse; 9) Patient is taking antipsychotic medication; 10) PatientHigh risk of suicide; 11) Pregnant or breastfeeding women; 12) Diseases of the left ear, acute exacerbation of asthma or chronic obstructive pulmonary disease, and other medical conditions that preclude percutaneous auricular vagus nerve stimulation; 13) Pacemakers, implantable cardioverter-defibrillators, or other implantable stimulators (vagus nerve stimulators or deep brain stimulators, etc.).

Design outcomes

Primary

MeasureTime frame
Hamilton Depression Scale Score;interleukin-6;ultrasensitive C-reactive protein;low density lipoprotein cholesterol;

Secondary

MeasureTime frame
Hamilton Anxiety Scale Score;Hamilton Depression Inventory Score Response Rate;Hamilton Depression Scale score remission rate;Beck Depression Rating Scale Score;Generalised Anxiety Scale Score;the Post-Traumatic Stress Disorder Cheeklist-CivilianVersion Scale Score;Quality of Life Scale Score;Heart Rate Variability;Left ventricular anteroposterior diameter (diastolic/systolic);left ventricular ejection fraction;fraction shorting;Peak early diastolic mitral inflow velocity/peak left atrial systolic mitral inflow velocity;septal thickness;Left ventricular posterior wall thickness;Ventricular wall motion analysis;Horizontal amino terminus B-type brain natriuretic peptide precursor;interleukin-1;ultrasensitive C-reactive protein;triglyceride;triglyceride;high density lipoprotein;Major adverse cardiovascular events;

Countries

China

Contacts

Public Contactwangang guo

The Second Affiliated Hospital of Air Force Medical University

wg_guoxn@163.com+86 186 2958 1753

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026