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Recruiting Observational

Perioperative Cerebral Function Assessment for Cardiac Surgery

NCT06660602 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2025-02-08
Last updated
2025-03-19

Condition(s) studied

Cardiac Surgery

Investigational drug(s) / intervention(s)

cardiac surgery

cardiac surgery: All kinds of cardiac surgeries

Study summary

Perioperative neurological complications in cardiovascular surgical procedures are associated with a significant risk of mortality and disability. This study is aimed at identifying the specific risk factors associated with these neurological complications during the perioperation and developing a comprehensive predictive model designed to enhance clinical decision-making and improve patient safety. The research is divided into three key phases: preoperative, intraoperative, and postoperative, each involving targeted evaluations and continuous monitoring to provide a thorough assessment of patient risk and outcomes.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion criteria: 1. Age 18-80 years; 2. Patients undergoing cardiovascular surgical procedures; 3. Able to understand and comply with the clinical trial protocol requirements, and willing to sign the informed consent form. Exclusion Criteria: 1. Inability to tolerate required diagnostic procedures, including neck CT angiography (CTA), head CT perfusion (CTP), or electroencephalography (EEG), due to underlying physical limitations or medical contraindications; 2. Severe renal insufficiency, characterized by a creatinine clearance of less than 30 mL/min (using the Cockcroft-Gault formula), serum creatinine levels exceeding twice the upper limit of normal, or any other form of clinically significant renal impairment; 3. Severe hepatic dysfunction, defined by ALT or AST levels greater than three times the upper limit of normal, or the presence of hepatic conditions such as acute or chronic hepatitis, cirrhosis, or other significant liver disorders; 4. Comorbid conditions that may compromise study participation or pose substantial risk to the patient, including, but not limited to, alcohol or substance abuse, malignancies, and severe diseases affecting the liver, kidneys, lungs, endocrine system (e.g., uncontrolled diabetes or thyroid disorders), or hematopoietic system; 5. Inability to cooperate with study procedures, whether due to cognitive, psychological, or physical factors that would impede compliance with protocol requirements; 6. Other conditions deemed unsuitable by the investigator, including any medical or non-medical factors that, in the investigator's assessment, may preclude safe or effective participation in the study.

Primary outcome measure(s)

  • Neurological complications within 7 (±3) days post-surgery including fatal or non-fatal stroke, coma, or movement disorders; cognitive dysfunction or delirium — From enrollment to the post-surgery within 7 (±3) days

Trial sites (1)

FacilityCityRegionStatus
Department of Neurology, Fuwai Hospital, Chinese Academy of Medical Sciences Beijing China Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06660602 on ClinicalTrials.gov ↗ ← All trials in China