Brain Protection and Neurological Prognosis in Patients With Heart Valve Disease Undergoing Cardiopulmonary Bypass Operation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change of brain volume before and after operation
研究概览
简要总结
The purpose of this study is to clarify the changes of neurocognitive function of patients undergoing cardiac valve disease before and after surgical treatment under cardiopulmonary bypass operation, and to predict the neurological prognosis of such patients through combined imaging technology, so as to improve and avoid the occurrence of postoperative neurological dysfunction in such patients.
详细描述
This study focuses on brain protection in patients with heart disease. The preoperative brain imaging and consciousness and cognition evaluation results, intraoperative brain monitoring indicators, adverse events of neurological function, brain imaging and consciousness and cognition evaluation results during the postoperative and follow-up periods were recorded. At the same time, serum markers related to perioperative neurological function were obtained to explore the relevant factors affecting neurocognitive function during the perioperative period. The research objectives to investigate the perioperative changes of neurocognitive function in patients undergoing heart valve surgery under cardiopulmonary bypass and the related factors affecting the prognosis of neurocognitive function.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 45-80 years old.
- •Accept heart biological valve replacement or heart valvuloplasty.
- •More than 6 years of Education.
- •At baseline, the score of Mini-mental State Examination (MMSE) scale is more than 23 points
排除标准
- •Patients who failed to obtain informed consent.
- •Preoperative diagnosis of stroke, epilepsy, history of craniocerebral surgery, cerebrovascular disease, psychosis and rescue patients with cardiopulmonary resuscitation before operation.
- •Alcoholism, illiteracy and left-handed.
- •There was severe organ hypoperfusion or organ dysfunction before operation, including: preoperative myocardial infarction < 90 days, renal failure or dialysis, severe liver injury, digestive tract ischemia, spinal cord ischemia and iliac artery occlusion.
- •There are contraindications to magnetic resonance examination, such as claustrophobia and metal implants in the body.
- •Pregnant or lactating women.
- •Participating in other clinical studies will affect the main indicators of this study.
结局指标
主要结局
Change of brain volume before and after operation
时间窗: before operation; 7-10 Days after operation; 1 month; 6-12months
The change of brain volume (mm3) are evaluated by structural 3DT1 weighted MRI. Freesurfer software is used to get the measured value of the volume.
Change of brain function connectivity before and after operation
时间窗: before operation; 7-10 Days after operation; 1 month; 6-12months
The change of brain functional connectivity intensity are evaluated by rest stage functional MRI. DPABI software based on MATLAB is used to get the measured the matrix value of functional connectivity.
次要结局
- Preliminary judge whether delirium occurs after operation(Witnin 96 hours after operation)
- Change of brain evaluate basic cognition before and after operation(before operation; 7-10 Days after operation; 1 month; 6-12months)
- Change of executive functions before and after operation evaluated by Trail-Making Test Part A(before operation; 7-10 Days after operation; 1 month; 6-12months)
- Change of executive functions before and after operation evaluated by Digit Symbol Coding score(before operation; 7-10 Days after operation; 1 month; 6-12months)
- Fine judge whether delirium occurs after operation(Witnin 96 hours after operation)
- Change of working memory before and after operation evaluated by Backward Digit Span(before operation; 7-10 Days after operation; 1 month; 6-12months)
- Change of plasma marker concentration before and after operation(before operation; immediately after operation; 1,2,3,4 Days after operation)
- Change of working memory before and after operation evaluated by Forward Digit Span(before operation; 7-10 Days after operation; 1 month; 6-12months)
- Change of language ability before and after operation(before operation; 7-10 Days after operation; 1 month; 6-12months)
- Change of serum marker concentration before and after operation(before operation; immediately after operation; 1,2,3,4 Days after operation)
研究者
Qianyan Liu
Principal Investgator
Nanjing University of Traditional Chinese Medicine