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Research on Neurological Prognosis of Patients Undergoing Heart Valve Surgery

N

Nanjing University of Traditional Chinese Medicine

Status

Not yet enrolling

Conditions

Heart Valve Diseases
Image

Treatments

Device: magnetic resonance image
Diagnostic Test: Neuropsychological scale

Study type

Observational

Funder types

Other

Identifiers

NCT05539261
82071993

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

45 to 80 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

30 participants in 2 patient groups

HVD
Description:
Heart Valve Disease
Treatment:
Diagnostic Test: Neuropsychological scale
Device: magnetic resonance image
HC
Description:
Healthy controls
Treatment:
Diagnostic Test: Neuropsychological scale
Device: magnetic resonance image

Trial contacts and locations

1

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Central trial contact

LiJun Bai, phD; Nengrui Guo

Data sourced from clinicaltrials.gov

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