Research on Neurological Prognosis of Patients Undergoing Heart Valve Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-10

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Heart Valve Diseases Image

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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HVD

Heart Valve Disease

magnetic resonance image

Intervention Type DEVICE

Imaging data were collected in a strong magnetic field

Neuropsychological scale

Intervention Type DIAGNOSTIC_TEST

Multi dimensional neuropsychological test

HC

Healthy controls

magnetic resonance image

Intervention Type DEVICE

Imaging data were collected in a strong magnetic field

Neuropsychological scale

Intervention Type DIAGNOSTIC_TEST

Multi dimensional neuropsychological test

Interventions

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magnetic resonance image

Imaging data were collected in a strong magnetic field

Intervention Type DEVICE

Neuropsychological scale

Multi dimensional neuropsychological test

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes