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Recruiting NCT06660602

NCT06660602 Perioperative Cerebral Function Assessment for Cardiac Surgery

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Clinical Trial Summary
NCT ID NCT06660602
Status Recruiting
Phase
Sponsor China National Center for Cardiovascular Diseases
Condition Cardiac Surgery
Study Type OBSERVATIONAL
Enrollment 1,845 participants
Start Date 2025-02-08
Primary Completion 2028-06

Trial Parameters

Condition Cardiac Surgery
Sponsor China National Center for Cardiovascular Diseases
Study Type OBSERVATIONAL
Phase N/A
Enrollment 1,845
Sex ALL
Min Age 18 Years
Max Age 80 Years
Start Date 2025-02-08
Completion 2028-06
Interventions
cardiac surgery

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Brief 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 Criteria

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 compro

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