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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nanjing University of Traditional Chinese Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Health Science Center of Xi'an Jiaotong University
Yuncheng First Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 10, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 5, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 14, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 14, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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