Research on Neurological Prognosis of Patients Undergoing Heart Valve Surgery

Heart Valve Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05539261
• Other study ID #: 82071993
• Status: Not yet recruiting
• Start date: September 10, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: September 2022
• Source: Nanjing University of Traditional Chinese Medicine
• Contact: Nengrui Guo
• Phone: 0086-17635599999
• Email: 657040251[@]qq.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Valve Diseases
• Image

Intervention

Device:
• magnetic resonance image
Imaging data were collected in a strong magnetic field

Diagnostic Test:
• Neuropsychological scale
Multi dimensional neuropsychological test

Locations

Country	Name	City	State
China	Yuncheng First Hospital	Yuncheng	Shanxi

Sponsors (3)

Lead Sponsor	Collaborator
Nanjing University of Traditional Chinese Medicine	School of Life Science and Technology, Xi'an Jiaotong University, Yuncheng First Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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