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NCT Number: NCT06791551

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

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.

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Key information

Conditions

Cardiac Surgery Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Confusion Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Stroke Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Neurology, Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing,

Beijing, Beijing Municipality, 100070, China

Location status: Recruiting

Location contact

Yao Feng, M.D

CONTACT

[email protected]

18810643595

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age range: 18-80 years old;
  • Surgical patients with heart disease;
  • Elective surgery;
  • Patients identified as high-risk for postoperative neurological complications; Previous stroke history; Moderate to severe stenosis of the head and neck arteries was evaluated;
  • Be able to understand and comply with the requirements of clinical trial protocols, and voluntarily sign informed consent forms.

Exclusion criteria

-

Treatment and study plan

active RIPC and tDCS

Device

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)

Device

received sham treatment with the same appearance instrument;

Primary outcomes

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

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Yao Feng, M.D.

CONTACT

[email protected]

18810643595

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Registry information

Official study title

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

Acronym: NICE

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jan 24, 2025
Registry last updated
Jun 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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