Research on Neurological Prognosis of Patients Undergoing Heart Valve Surgery

September 10, 2022 updated by: Qianyan Liu, Nanjing University of Traditional Chinese Medicine

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanxi
      • Yuncheng, Shanxi, China
        • Yuncheng First Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HVD
Heart Valve Disease
Device: magnetic resonance image
Imaging data were collected in a strong magnetic field
Diagnostic test: Neuropsychological scale
Multi dimensional neuropsychological test
HC
Healthy controls
Device: magnetic resonance image
Imaging data were collected in a strong magnetic field
Diagnostic test: Neuropsychological scale
Multi dimensional neuropsychological test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of brain volume before and after operation
Time Frame: 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.
before operation; 7-10 Days after operation; 1 month; 6-12months
Change of brain function connectivity before and after operation
Time Frame: 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.
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
Time Frame: before operation; 7-10 Days after operation; 1 month; 6-12months
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
Time Frame: before operation; 7-10 Days after operation; 1 month; 6-12months
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
Time Frame: before operation; 7-10 Days after operation; 1 month; 6-12months
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
Time Frame: before operation; 7-10 Days after operation; 1 month; 6-12months
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
Time Frame: before operation; 7-10 Days after operation; 1 month; 6-12months
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
Time Frame: before operation; 7-10 Days after operation; 1 month; 6-12months
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
Time Frame: Witnin 96 hours 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
Time Frame: Witnin 96 hours 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
Time Frame: before operation; immediately after operation; 1,2,3,4 Days 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
Time Frame: before operation; immediately after operation; 1,2,3,4 Days 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing University of Traditional Chinese Medicine

Collaborators

Health Science Center of Xi'an Jiaotong University
Yuncheng First Hospital

Investigators

  • Principal Investigator: Nengrui Guo, Yuncheng First Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 10, 2022

Primary Completion (Anticipated)

December 31, 2025

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

September 5, 2022

First Submitted That Met QC Criteria

September 10, 2022

First Posted (Actual)

September 14, 2022

Study Record Updates

Last Update Posted (Actual)

September 14, 2022

Last Update Submitted That Met QC Criteria

September 10, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 82071993

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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