Assessing brain function during cardiac surgery
Perioperative Cerebral Function Assessment for Cardiac Surgery
This study is trying to find out what factors might lead to brain problems after heart surgery by checking patients' brain function before, during, and after the operation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1845 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | China National Center for Cardiovascular Diseases Government |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06660602 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify risk factors for neurological complications associated with cardiac surgery by conducting a comprehensive assessment of patients before, during, and after the surgical procedure. It involves detailed evaluations of medical histories and cerebral function preoperatively, real-time monitoring of cerebral blood flow and oxygenation intraoperatively, and postoperative assessments for cognitive dysfunction and other complications. The goal is to develop a predictive model that enhances clinical decision-making and improves patient safety by reducing the incidence of neurological complications.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-80 who are scheduled to undergo cardiovascular surgical procedures.
Not a fit: Patients with severe renal or hepatic dysfunction, or those unable to tolerate required diagnostic procedures, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved patient safety and outcomes by providing clinicians with a reliable tool for assessing and mitigating risks associated with cardiac surgery.
How similar studies have performed: Other studies have shown success in using similar monitoring techniques to assess neurological risks during cardiac procedures, indicating that this approach has potential.
Eligibility criteria
Show full inclusion / exclusion 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 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.
Where this trial is running
Beijing
- Department of Neurology, Fuwai Hospital, Chinese Academy of Medical Sciences — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Yao Feng, Dr.
- Email: fengyao_dr@sina.com
- Phone: 18810643595
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.