Non‑drug, non‑invasive treatments given before heart surgery to protect the brain
Non-pharmacologial, Non-invassive Intervention Before Cardiac Surgry: a Randomized Controlled Trial
This trial will test whether remote ischemic preconditioning (RIPC) and transcranial electrical stimulation (tDCS) given before elective heart surgery can reduce stroke, delirium, and other brain complications in adults at high risk.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | China National Center for Cardiovascular Diseases Government |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06791551 on ClinicalTrials.gov |
What this trial studies
In this randomized controlled trial, adults aged 18–80 who are scheduled for elective cardiac surgery and identified as high risk for postoperative neurological complications will be assigned to receive active remote ischemic preconditioning and transcranial electrical stimulation or a sham/no-treatment control before surgery. Researchers will monitor for perioperative neurological outcomes such as stroke, delirium, and cognitive decline, and will collect safety data on the two non‑invasive interventions. The interventions are non‑pharmacological and applied prior to the operative period, with follow-up during the immediate postoperative phase. Results will compare rates of neurological complications and adverse events between the groups.
Who should consider this trial
Good fit: Adults 18–80 years old scheduled for elective cardiac surgery who are judged high-risk for postoperative neurological complications (for example, prior stroke or moderate-to-severe stenosis of head/neck arteries) and who can give informed consent.
Not a fit: People having emergency surgery, those outside the age range, low-risk surgical patients, or those unable to consent or comply with the protocol are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, these non-drug, non-invasive procedures could lower the risk of stroke, delirium, and other brain complications after cardiac surgery.
How similar studies have performed: Previous trials of remote ischemic preconditioning in cardiac surgery have produced mixed results, and use of transcranial electrical stimulation for perioperative brain protection remains relatively novel with limited clinical evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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: \-
Where this trial is running
Beijing, Beijing Municipality
- Department of Neurology, Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing, — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Yao Feng, M.D.
- Email: fengyao_dr@sina.com
- Phone: 18810643595
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.