Perioperative Cerebral Function Assessment for Cardiac Surgery (NCT06660602) | Clinical Trial Compass
RecruitingNot Applicable
Perioperative Cerebral Function Assessment for Cardiac Surgery
China1,845 participantsStarted 2025-02-08
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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✓. Able to understand and comply with the clinical trial protocol requirements, and willing to sign the informed consent form.
Exclusion criteria
✕. 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;
✕. 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;
✕. 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;
✕. 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;
What they're measuring
1
Neurological complications within 7 (±3) days post-surgery including fatal or non-fatal stroke, coma, or movement disorders; cognitive dysfunction or delirium
Timeframe: From enrollment to the post-surgery within 7 (±3) days
Trial details
NCT IDNCT06660602
SponsorChina National Center for Cardiovascular Diseases
✕. Inability to cooperate with study procedures, whether due to cognitive, psychological, or physical factors that would impede compliance with protocol requirements;
✕. 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.