Clinical trial NCT06791551: Non-pharmacologial, Non-invassive Intervention Before Cardiac Surgery: a Randomized Controlled Trial
Official title: Non-pharmacologial, Non-invassive Intervention Before Cardiac Surgry: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiac Surgery
Keywords: cardiac surgery
cognitive function
stroke
delirium
non-invasive neuromodulation
Remote Ischemic Preconditioning
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2025-01-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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:

-

Primary outcomes:
measure: The incidence of neurological complications 7 (± 3) days after cardiac surgery
timeFrame: From enrollment to the post-surgery within 7 (±3) days
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Neurology, Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing,
state: Beijing
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Shujuan Li, M.D.
role: STUDY_DIRECTOR
References:
citation: Goede LL, Oxenford S, Kroneberg D, Meyer GM, Rajamani N, Neudorfer C, Krause P, Lofredi R, Fox MD, Kuhn AA, Horn A. Linking Invasive and Noninvasive Brain Stimulation in Parkinson's Disease: A Randomized Trial. Mov Disord. 2024 Nov;39(11):1971-1981. doi: 10.1002/mds.29940. Epub 2024 Jul 25.
citation: Li C, Tao M, Chen D, Wei Q, Xiong X, Zhao W, Tan W, Yang J, Han Y, Zhang H, Zhang S, Liu H, Cao JL. Transcranial Direct Current Stimulation for Anxiety During Laparoscopic Colorectal Cancer Surgery: A Randomized Clinical Trial. JAMA Netw Open. 2024 Apr 1;7(4):e246589. doi: 10.1001/jamanetworkopen.2024.6589.
citation: Law YM, Hsu C, Hingorani SR, Richards M, McMullan DM, Jefferies H, Himmelfarb J, Katz R. Randomized controlled trial of remote ischemic preconditioning in children having cardiac surgery. J Cardiothorac Surg. 2024 Jan 3;19(1):5. doi: 10.1186/s13019-023-02450-8.
citation: Nyquist P, Georgakis MK. Remote ischemic preconditioning effects on brain vasculature. Neurology. 2019 Jul 2;93(1):15-16. doi: 10.1212/WNL.0000000000007724. Epub 2019 May 29. No abstract available.
citation: Hardt JLS, Pohlmann P, Reissfelder C, Rahbari NN. Remote ischemic preconditioning for reduction of ischemia-reperfusion injury after hepatectomy: A randomized sham-controlled trial. Surgery. 2024 Feb;175(2):424-431. doi: 10.1016/j.surg.2023.09.042. Epub 2023 Nov 10.