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RecruitingNCT06791551NICEUpdated Jun 6, 2025

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

An interventional study of active RIPC and tDCS and Sham (No Treatment) in Cardiac Surgery, sponsored by China National Center for Cardiovascular Diseases. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-06-06.

Sponsored by China National Center for Cardiovascular Diseases · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

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.

02

Conditions studied

  • Cardiac Surgery

Keywords

  • cardiac surgery
  • cognitive function
  • stroke
  • delirium
  • non-invasive neuromodulation
  • Remote Ischemic Preconditioning
03

In context

Lead sponsor

China National Center for Cardiovascular Diseases is the lead sponsor of 256 studies on the registry; 134 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts 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

Exclusion Criteria:

-

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
200 participants (estimated)

Study arms

  • Active comparator
    active RIPC and tDCS

    RIPC and tDCS twice every day for 3 days before cardiac surgery

  • Sham comparator
    sham RIPC and tDCS

    Sham RIPC and tDCS twice every day for 3 days before cardiac surgery

    Device: Sham (No Treatment)

Interventions

  • Deviceactive 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;

  • DeviceSham (No Treatment)

    received sham treatment with the same appearance instrument;

06

What researchers measure

Primary outcomes

  1. The incidence of neurological complications 7 (± 3) days after cardiac surgery

    Lethal or non lethal stroke, coma, or motor impairment; Cognitive impairment or delirium

    Time frame: From enrollment to the post-surgery within 7 (±3) days

07

Study locations

1 of 1 sites recruiting
  • Department of Neurology, Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing,
    Beijing, Beijing 100070, China
    Recruiting
08

References and documents

Publications

  • 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. PubMed 39051611 ↗
  • 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. PubMed 38635271 ↗
  • 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. PubMed 38172875 ↗
  • 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. PubMed 31142632 ↗
  • 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. PubMed 37951812 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06791551
Lead sponsor
China National Center for Cardiovascular Diseases
Responsible party
Shujuan Li (M.D., China National Center for Cardiovascular Diseases) — Principal investigator
First posted
Jan 24, 2025
Start date
Jun 10, 2025 (estimated)
Primary completion
Jul 31, 2028 (estimated)
Completion
Jul 31, 2028 (estimated)
Last update
Jun 6, 2025

Study contacts

Yao Feng, M.D.
Contact
fengyao_dr@sina.com
18810643595
Shujuan Li, M.D.
study director · Chinese Academy of Medical Sciences, Fuwai Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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