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

National Center for Cardiovascular Diseases

Status: Enrolling

Conditions: Cardiac Surgery

Treatments: Device: Sham (No Treatment); Device: active RIPC and tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT06791551

2024-2460-1

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

active RIPC and tDCS

Active Comparator group

Description:

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

sham RIPC and tDCS

Sham Comparator group

Description:

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

Treatment:

Device: Sham (No Treatment)