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Recruiting Not applicable

Non-pharmacologial, Non-invassive Intervention Before Cardiac Surgery: a Randomized Controlled Trial

NCT06791551 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2025-06-10
Last updated
2025-06-06

Condition(s) studied

Cardiac Surgery

Investigational drug(s) / intervention(s)

active RIPC and tDCSSham (No Treatment)

active RIPC and tDCS: Preoperative use of a therapeutic device with sleeves fixed on the upper side of both arms, compressing the bilateral brachial arteries to 200mmHg for 5 minutes, resting for 5 minutes, repeating 5 times, recorded as 1 time, training once in the morning and afternoon each day, and continuing treatment for at least 3 days; Administer transcranial electrical stimulation, 2mA, 30min, for 3 days;

Sham (No Treatment): received sham treatment with the same appearance instrument;

Study summary

Perioperative neurological complications in cardiovascular surgical procedures are associated with a significant risk of mortality and disability. The goal of this clinical trial is to learn if ischemic preconditioning and transcranial electrical stimulation to reduce perioperative neurological complications. It will also learn about the safety of remote ischemic preconditioning and transcranial electrical stimulation before cardiac surgery. The main questions it aims to answer are "Do remote ischemic preconditioning and transcranial electrical stimulation make good effect on perioperative neurological complications?" "Are remote ischemic preconditioning and transcranial electrical stimulation safe?" Researchers will compare remote ischemic preconditioning and transcranial electrical stimulation to traditional treatment to see if remote ischemic preconditioning and transcranial electrical stimulation work to reduce perioperative neurological complications.

Participants will:Undergo remote ischemic preconditioning and transcranial electrical stimulation or sham treatment twice every day for 3 days before surgery.

Undertake psychological assessment and clinical symptom follow-up after cardiac surgery.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age range: 18-80 years old; 2. Surgical patients with heart disease; 3. Elective surgery; 4. Patients identified as high-risk for postoperative neurological complications; Previous stroke history; Moderate to severe stenosis of the head and neck arteries was evaluated; 5. Be able to understand and comply with the requirements of clinical trial protocols, and voluntarily sign informed consent forms. Exclusion Criteria: \-

Primary outcome measure(s)

  • The incidence of neurological complications 7 (± 3) days after cardiac surgery — From enrollment to the post-surgery within 7 (±3) days
    Lethal or non lethal stroke, coma, or motor impairment; Cognitive impairment or delirium

Trial sites (1)

FacilityCityRegionStatus
Department of Neurology, Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing, Beijing Beijing Municipality Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06791551 on ClinicalTrials.gov ↗ ← All trials in China