An observational study in Coronary Heart Disease and Image, sponsored by Nanjing University of Traditional Chinese Medicine. Not yet recruiting at 1 site in China. Open to participants aged 40 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-08.
Sponsored by Nanjing University of Traditional Chinese Medicine · Observational
The purpose of this study is to elucidate the imaging mechanisms of cognitive function changes in patients with coronary heart disease before and after surgery or conservative treatment, and to evaluate and predict the postoperative neurological function recovery and cerebrovascular health level of patients by combining serum markers and patient cardiovascular health evaluation indicators.
The focus of this study is to elucidate the impact of coronary heart disease on the morphology and cognitive changes of cerebral blood vessels in patients. Record imaging data, neuropsychological cognitive scales, serum markers, adverse cardiac events, and patient evaluation indicators before and after clinical treatment and follow-up period, and explore relevant factors affecting changes in cerebrovascular morphology and cognitive function.
1,520 studies on the registry are indexed under Coronary Disease; 167 are open to participants now.
This study's planned enrollment of 100 is below the median of 916 across 478 observational studies indexed under Coronary Disease.
Browse Coronary Disease studies →Nanjing University of Traditional Chinese Medicine is the lead sponsor of 17 studies on the registry; 6 are open to participants now.
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All of the patients of CAD（coronary heart disease ）surgical treatment group and CAD（coronary heart disease ）conservative treatment group are in-patients and out-patients in the cardiac surgery department from the research center. The subjects of healthy control group are recruited from community.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: magnetic resonance image · Diagnostic Test: Neuropsychological scale
Device: magnetic resonance image · Diagnostic Test: Neuropsychological scale
Device: magnetic resonance image · Diagnostic Test: Neuropsychological scale
Imaging data were collected in a strong magnetic field
Multi dimensional neuropsychological test
Change of brain volume before and after treatment
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.
Time frame: before operation; 3-10 Days after operation; 1 month; 6-12months
Change of cerebrovascular morphology before and after treatment
The change of Cerebral vessel density, caliber and tortuosity, brain white matter hyperintensity lesion count
Time frame: before operation; 3-10 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.
Time frame: before operation; 3-10 Days after operation; 1 month; 6-12months
Change of serum marker concentration before and after operation
The change of serum marker concentration is evaluated by inflammatory cytokine.
Time frame: before operation; 3-10 Days after operation; 1 month; 6-12months
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.
Time frame: before operation; 3-10 Days after operation; 1 month; 6-12months
Change of cardiovascular risk factors before and after operation
The change of cardiovascular risk factors is evaluated by blood routine and patients' living habits
Time frame: before operation; 3-10 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.
Time frame: before operation; 3-10 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.
Time frame: before operation; 3-10 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.
Time frame: before operation; 3-10 Days after operation; 1 month; 6-12months
Change of executive functions before and after operation evaluated by Trail-Making Test Part B
The change of executive functions are first evaluated by Trail-Making Test Part B 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.It is a supplement to Trail-Making Test Part A, which is optional for patients who are not familiar with the English alphabetical order
Time frame: before operation; 3-10 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.
Time frame: before operation; 3-10 Days after operation; 1 month; 6-12months
Change of episodic memory functions before and after operation evaluated by Auditory Verbal Learning test
The change of episodic memory are evaluated by Auditory Verbal Learning test(AVLT-H).
Time frame: before operation; 3-10 Days after operation; 1 month; 6-12months
This study is not yet recruiting, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Nanjing University of Traditional Chinese Medicine