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NCT Number: NCT07202689

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. The incidence of perioperative stroke

    Time frame: 48 hours preoperatively and 3-7 days postoperatively

    Perioperative stroke is diagnosed by MRI

Study contacts

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

Yuming Peng, MD,Ph.D

CONTACT

[email protected]

8610-59976658

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

The Predictive Value of Multimodal Brain Monitoring for Perioperative Stroke in Cardiac Surgery Patients: A Prospective Observational Study

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Oct 2, 2025
Registry last updated
Oct 2, 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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