Heart Valve DiseasesNCT05539261
Research on Neurological Prognosis of Patients Undergoing Heart Valve Surgery
An observational study of Heart Valve Diseases and Image, run by Nanjing University of Traditional Chinese Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Valve Diseases, Image
- What is being tested?
- magnetic resonance image and Neuropsychological scale
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2022to 31 Dec 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site
Yuncheng First Hospital
Yuncheng, Shanxi
Nengrui Guo, 0086-17635599999, 657040251@qq.com
Lijun Bai, PhD, 0086-15129034948, bailijun@xjtu.edu.cn
About this study
Official title: 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.
Read the 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.
- Conditions
- Heart Valve Diseases, Image
- Being tested
- magnetic resonance image, Neuropsychological scale
- Keywords
- Heart Valve Diseases, Cardiopulmonary bypass, MRI Imaging, Neuropsychological assessment
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnetic resonance imageDevice
Imaging data were collected in a strong magnetic field
Neuropsychological scaleDiagnostic test
Multi dimensional neuropsychological test
| Study group | Role | What they receive |
|---|---|---|
| HVD | Heart Valve Disease Receives: Device: magnetic resonance image; Diagnostic Test: Neuropsychological scale | |
| HC | Healthy controls Receives: Device: magnetic resonance image; Diagnostic Test: Neuropsychological scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: before operation; 7-10 Days after operation; 1 month; 6-12months
Secondary outcomes (10)
Change of brain evaluate basic cognition before and after operation
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.
Measured: 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
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.
Measured: 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
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.
Measured: before operation; 7-10 Days after operation; 1 month; 6-12months
Change of working memory before and after operation evaluated by Forward Digit Span
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.
Measured: before operation; 7-10 Days after operation; 1 month; 6-12months
Change of working memory before and after operation evaluated by Backward Digit Span
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.
Measured: before operation; 7-10 Days after operation; 1 month; 6-12months
Change of language ability before and after operation
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.
Measured: before operation; 7-10 Days after operation; 1 month; 6-12months
Preliminary judge whether delirium occurs 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.
Measured: Witnin 96 hours after operation
Fine judge whether delirium occurs 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.
Measured: Witnin 96 hours after operation
Change of plasma marker concentration before and after operation
The change of plasma marker concentration is evaluated by neurofilament light chain(NFL) protein extracted from plasma.
Measured: before operation; immediately after operation; 1,2,3,4 Days after operation
Change of serum marker concentration before and after operation
The change of serum marker concentration is evaluated by inflammatory cytokine.
Measured: before operation; immediately after operation; 1,2,3,4 Days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start10 Sep 2022 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Valve DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Nanjing University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Xi'an Jiaotong University, Yuncheng First Hospital
- Responsible party
- Principal investigator, Qianyan Liu, Nanjing University of Traditional Chinese Medicine
- Investigators
- Nengrui Guo, Principal investigator, Yuncheng First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05539261
- Sponsor's protocol ID
- 82071993
- Status last verified
- Sep 2022
- First submitted
- 5 Sep 2022
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Protection and Neurological Prognosis in Patients With Heart Valve Disease Undergoing Cardiopulmonary Bypass Operation
- ClinicalTrials.gov ID
- NCT05539261
- Acronym / sponsor ID
- 82071993
- Conditions
- Heart Valve Diseases, Image
- Keywords
- Heart Valve Diseases, Cardiopulmonary bypass, MRI Imaging, Neuropsychological assessment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Nanjing University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Xi'an Jiaotong University, Yuncheng First Hospital
- Study start
- 10 Sep 2022 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 14 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HVD | – | Device: magnetic resonance image, Diagnostic Test: Neuropsychological scaleHeart Valve Disease |
| HC | – | Device: magnetic resonance image, Diagnostic Test: Neuropsychological scaleHealthy controls |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| magnetic resonance imageImaging data were collected in a strong magnetic field | Device | HC, HVD |
| Neuropsychological scaleMulti dimensional neuropsychological test | Diagnostic test | HC, HVD |
Primary outcome
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.
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.
10 secondary outcomes
Change of brain evaluate basic cognition before and after operation
Time frame: 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
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
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
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
Change of language ability before and after operation
Time frame: 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
Fine judge whether delirium occurs after operation
Time frame: 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
Change of serum marker concentration before and after operation
Time frame: before operation; immediately after operation; 1,2,3,4 Days after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nengrui Guo principal investigator
Yuncheng First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Valve Diseases and Image, run by Nanjing University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nengrui Guo (0086-17635599999, 657040251@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of brain volume before and after operation (time frame: before operation; 7-10 Days after operation; 1 month; 6-12months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2022.