Clinical trial NCT05539261: Research on Neurological Prognosis of Patients Undergoing Heart Valve Surgery
Official title: Brain Protection and Neurological Prognosis in Patients With Heart Valve Disease Undergoing Cardiopulmonary Bypass Operation
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Heart Valve Diseases
Image
Keywords: Heart Valve Diseases
Cardiopulmonary bypass
MRI Imaging
Neuropsychological assessment
Lead sponsor: Nanjing University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Xi'an Jiaotong University
name: Yuncheng First Hospital
First posted: 2022-09-14
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All of the patients of HVD group are in-patients and out-patients in the cardiac surgery department from the research center. The subjects of control group are recruited from community.

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change of brain volume before and after operation
timeFrame: before operation; 7-10 Days after operation; 1 month; 6-12months
measure: Change of brain function connectivity before and after operation
timeFrame: before operation; 7-10 Days after operation; 1 month; 6-12months
Secondary outcomes:
measure: Change of brain evaluate basic cognition before and after operation
timeFrame: before operation; 7-10 Days after operation; 1 month; 6-12months
measure: Change of executive functions before and after operation evaluated by Trail-Making Test Part A
timeFrame: before operation; 7-10 Days after operation; 1 month; 6-12months
measure: Change of executive functions before and after operation evaluated by Digit Symbol Coding score
timeFrame: before operation; 7-10 Days after operation; 1 month; 6-12months
measure: Change of working memory before and after operation evaluated by Forward Digit Span
timeFrame: before operation; 7-10 Days after operation; 1 month; 6-12months
measure: Change of working memory before and after operation evaluated by Backward Digit Span
timeFrame: before operation; 7-10 Days after operation; 1 month; 6-12months
measure: Change of language ability before and after operation
timeFrame: before operation; 7-10 Days after operation; 1 month; 6-12months
measure: Preliminary judge whether delirium occurs after operation
timeFrame: Witnin 96 hours after operation
measure: Fine judge whether delirium occurs after operation
timeFrame: Witnin 96 hours after operation
measure: Change of plasma marker concentration before and after operation
timeFrame: before operation; immediately after operation; 1,2,3,4 Days after operation
measure: Change of serum marker concentration before and after operation
timeFrame: before operation; immediately after operation; 1,2,3,4 Days after operation
Other outcomes:
Locations:
city: Yuncheng
country: China
facility: Yuncheng First Hospital
state: Shanxi
Study officials:
affiliation: Yuncheng First Hospital
name: Nengrui Guo
role: PRINCIPAL_INVESTIGATOR
References: