The Predictive Value of Multimodal Brain Monitoring for Perioperative Stroke in Cardiac Surgery Patients

NCT07202689 | Not Yet Recruiting

• 1 other identifier: 2025-09-10
• Study Type: observational
• Target: 369
• Locations: 0 countries
• Sites: N/A

Brief Summary

Postoperative stroke following cardiac surgery is associated with a ninefold increase in mortality risk compared to patients without stroke. Perioperative monitoring in cardiac surgery involves a range of complex and diverse techniques, presenting significant challenges for anesthetic management. Multimodal brain monitoring technology offers a novel approach to cerebral protection during the perioperative period of cardiac surgery by integrating hemodynamic parameters, autonomic nervous responses, cerebral oxygen saturation and indices, electroencephalographic activity, and cerebral blood flow velocity. Therefore, this study aims to evaluate the comprehensive early-warning efficacy of multimodal brain monitoring for perioperative stroke in cardiac surgery patients, determine the cumulative incidence of perioperative stroke-including covert stroke-and provide a new theoretical basis for optimizing cerebral protection strategies in cardiac surgery.

Conditions

Multimodal Monitoring; Perioperative Stroke; Covert Stroke

Outcome Measures

Primary Outcomes (1)

• The incidence of perioperative stroke

  Perioperative stroke is diagnosed by MRI

  48 hours preoperatively and 3-7 days postoperatively

Study Arms (2)

With stroke

Device: Multimodal monitoring

Without stroke

Device: Multimodal monitoring

Interventions

Multimodal monitoring DEVICE

Multimodal monitoring technology offers a novel approach to cerebral protection during the perioperative period of cardiac surgery by integrating hemodynamic parameters, autonomic nervous responses, cerebral oxygen saturation and indices, electroencephalographic activity, and cerebral blood flow velocity.

With stroke; Without stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The population will be selected from patients who schedule to receive elective cardiac surgery in Beijing Tiantan Hospital.

You may qualify if:

• Patients scheduled for elective cardiac surgery
• Presence of at least one of the following high-risk factors for stroke: a.Peripheral vascular disease (history of peripheral artery bypass grafting, amputation for ischemia, Ankle-Brachial Pressure Index \< 0.9, or history of abdominal aortic aneurysm repair).b.Cerebrovascular disease (history of stroke, transient ischemic attack, or carotid stenosis \>70%).c.Renal insufficiency (Glomerular Filtration Rate \< 60 mL/min/1.73m²).d.Diabetes mellitus (requiring oral hypoglycemic agents and/or insulin therapy).e.Urgent coronary artery bypass grafting (inpatient requiring revascularization due to acute coronary syndrome or myocardial infarction).f.Recent smoking history (within 1 year).g.Left ventricular ejection fraction \< 35%
• Provision of signed informed consent

You may not qualify if:

• Contraindication to magnetic resonance imaging (e.g., claustrophobia, inability to lie flat for the duration of the study, presence of a pacemaker or implantable cardioverter-defibrillator, or other metallic implants)
• Inability to complete cognitive function assessments
• Patients with psychiatric, legal disabilities or under legal guardianship
• Life expectancy of less than 3 months
• Women who are lactating or pregnant
• Diagnosis of any type of dementia

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Officials

• Yuming Peng, MD,Ph.D

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuming Peng, MD,Ph.D

CONTACT

8610-59976658; florapym766@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy chief of Department of Anesthesiology

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: October 2, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share