Research on Neurological Prognosis of Patients Undergoing Heart Valve Surgery

NCT05539261 | Unknown

• 1 other identifier: 82071993
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Valve Diseases; Image

Keywords

Heart Valve Diseases; Cardiopulmonary bypass; MRI Imaging; Neuropsychological assessment

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• 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

• 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 working memory before and after operation evaluated by Backward Digit Span

  before operation; 7-10 Days after operation; 1 month; 6-12months

Study Arms (2)

HVD

Heart Valve Disease

Device: magnetic resonance image; Diagnostic Test: Neuropsychological scale

HC

Healthy controls

Device: magnetic resonance image; Diagnostic Test: Neuropsychological scale

Interventions

magnetic resonance image DEVICE

Imaging data were collected in a strong magnetic field

HC; HVD

Neuropsychological scale DIAGNOSTIC_TEST

Multi dimensional neuropsychological test

HC; HVD

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing University of Traditional Chinese Medicine: lead
• Xi'an Jiaotong University: collaborator
• Yuncheng First Hospital: collaborator

Study Sites (1)

Yuncheng First Hospital

Yuncheng, Shanxi, China

Location

MeSH Terms

Conditions

Heart Valve Diseases

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Nengrui Guo

  Yuncheng First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nengrui Guo

CONTACT

0086-17635599999; 657040251@qq.com

LiJun Bai, phD

CONTACT

0086-15129034948; bailijun@xjtu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investgator

Study Record Dates

• First Submitted: September 5, 2022
• First Posted: September 14, 2022
• Study Start: September 10, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 14, 2022

Record last verified: 2022-09

Locations

CN (1)