Research on Neurological Prognosis of Patients Undergoing Heart Valve Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Brain Protection and Neurological Prognosis in Patients With Heart Valve Disease Undergoing Cardiopulmonary Bypass Operation

Conditions
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Image, Heart Valve Diseases

Intervention / Treatment
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* Device: magnetic resonance image
* Diagnostic Test: Neuropsychological scale


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HVD<br>Heart Valve Disease | Device: magnetic resonance image<br>* Imaging data were collected in a strong magnetic field<br>Diagnostic Test: Neuropsychological scale<br>* Multi dimensional neuropsychological test<br>|
| HC<br>Healthy controls | Device: magnetic resonance image<br>* Imaging data were collected in a strong magnetic field<br>Diagnostic Test: Neuropsychological scale<br>* Multi dimensional neuropsychological test<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of brain volume before and after operation | 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. | before operation; 7-10 Days after operation; 1 month; 6-12months | 
| Change of brain function connectivity before and after operation | 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. | before operation; 7-10 Days after operation; 1 month; 6-12months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of brain evaluate basic cognition before and after operation | The change of basic cognition is evaluated by Mini-mental State Examination. The minimum value is 0 , and the maximum value is 30. The higher scores mean a better outcome. | 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 | The change of executive functions are first evaluated by Trail-Making Test Part A test. The minimum value is 0 , and the maximum value is 30. This test has no clear maximum and minimum values. If the test completion time exceeds 79 seconds, it means the outcome is abnormal. The higher scores mean a worse outcome. | 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 | The change of executive functions are second evaluated by Digit Symbol Coding score. The minimum value is 0 , and the maximum value is not clear. The normal range of results is 56.53 ± 20.17. The higher scores mean a better outcome. | before operation; 7-10 Days after operation; 1 month; 6-12months | 
| Change of working memory before and after operation evaluated by Forward Digit Span | The change of working memory is first evaluated by Forward Digit Span. The minimum value is 0 , and the maximum value is not clear. The normal range of results is 7.75±1.47. The higher scores mean a better outcome. | before operation; 7-10 Days after operation; 1 month; 6-12months | 
| Change of working memory before and after operation evaluated by Backward Digit Span | The change of working memory is second evaluated by Backward Digit Span. The minimum value is 0 , and the maximum value is not clear. The normal range of results is 5.36±1.91. The higher scores mean a better outcome. | before operation; 7-10 Days after operation; 1 month; 6-12months | 
| Change of language ability before and after operation | The change of language ability is evaluated by Chinese Version Verbal Fluency Test. The minimum value is 0 , and the maximum value is not clear. The normal range of results is 19.43±4.81. The higher scores mean a better outcome. | before operation; 7-10 Days after operation; 1 month; 6-12months | 
| Preliminary judge whether delirium occurs after operation | Delirium is preliminary evaluate using confusion assessment method(CAM). The minimum value is 0 , and the maximum value is 4. The higher scores mean a worse outcome. | Witnin 96 hours after operation | 
| Fine judge whether delirium occurs after operation | Delirium is fine evaluated using Delirium Rating Scale(DRS-R-98). The minimum value is 0 , and the maximum value is 39. The higher scores mean a worse outcome. | Witnin 96 hours after operation | 
| Change of plasma marker concentration before and after operation | The change of plasma marker concentration is evaluated by neurofilament light chain(NFL) protein extracted from plasma. | before operation; immediately after operation; 1,2,3,4 Days after operation | 
| Change of serum marker concentration before and after operation | The change of serum marker concentration is evaluated by inflammatory cytokine. | before operation; immediately after operation; 1,2,3,4 Days after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Valve Diseases, Cardiopulmonary bypass, MRI Imaging, Neuropsychological assessment