Cognitive Impairment , Neuroimaging and Inflammatory Markers in Patients With Subcortical Ischemic Vascular Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Hebei General Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Hebei General Hospital
ClinicalTrials.gov Identifier:
NCT01418885
First received: August 16, 2011
Last updated: NA
Last verified: August 2010
History: No changes posted
  Purpose

SIVD is characterised by extensive cerebral white matter lesions (WML) and lacunar infarcts in deep grey and white matter structures. The relationship between SIVD and cognition is unclear, in part because of methodological inconsistencies across studies.

Diffusion tensor imaging (DTI) is a non-invasive water diffusion technique and can be used for quantitatively measuring the degree and directionality of the displacement distribution of water molecules. 1H magnetic resonance spectroscopy (1H-MRS) is a valuable tool for the assessment of several biochemical compounds in the brain in vivo, such as N-acetylaspartate (NAA), myoinositol (mI), Choline (Cho) and Creatine (Cr). There were few reports considering the relationship among MRS, DTI and cognitive impairment of SIVD. Combining MRS with DTI may provide valuable information about the pathophysiological changes underlying DTI abnormalities and help us to better understand the SIVD process. It has been proposed that the pathogenesis of SIVD related to cerebral small vessel disease caused by various mechanisms. Inflammation plays an important role in the pathogenesis of SIVD. The examination of inflammatory markers in relation to VaD might be benefit to early treatment.

In this study we applied neuropsychological tests, conventional MRI scanning, DTI, 1H-MRS techniques and inflammatory markers to estimate neuropsychological profile and white matter characteristics of imaging in patients with SIVD. Moreover, the relationship between WML and cognitive function impairment was also investigated. It could be possible to gain reliable data which is benefit to early diagnosis and treatment of cognitive impairment in SIVD.


Condition
Other Generalized Ischemic Cerebrovascular Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Correlation Exploration Between Cognitive Impairment and Neuroimaging and Inflammatory Markers in Patients With Subcortical Ischemic Vascular Disease

Resource links provided by NLM:


Further study details as provided by Hebei General Hospital:

Biospecimen Retention:   None Retained

serum


Estimated Enrollment: 100
Study Start Date: September 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
SIVD,VaD
vascular disease in patients with SIVD
SIVD,VCIND
vascular cognitive impairment no dementia in patients with SIVD
normal controls
normal elderly controls

Detailed Description:
  1. Contributions of white matter lesions to cognitive impairment in patients with subcortical ischemic vascular disease

    1. Extensive neuropsychological tests including MMSE and covering 5 cognitive domains including memory, executive, visuospatial, attention and language function would be performed on patients with SIVD and normal elderly controls matched in age and gender. The patients would be divided into VaD and VCIND group.
    2. Age-related white matter change rating scale, which is a visual rating scale developed by Wahlund, would be used to qualitative measure and locate the WML.
    3. Correlation analysis and hierarchical multiple regression analysis would be used to examine the relationship between general cognitive function and WML.
  2. Evaluation of microstructural white matter lesions in patients with subcortical vascular cognitive impairment using diffusion tensor imaging

    1. SIVD patients divided into VaD and VCIND group and normal elderly controls matched in age and gender would be recruited. DTI images would be acquired, and fractional anisotropy (FA), mean diffusivity (MD) of normal-appearing white matter in cerebral lobes would be determined.
    2. These diffusion measurements were compared across the 3 groups, and significant differences would be further performed for correlation with tests of comprehensive cognitive function.
  3. Evaluation of the lesions in thalamus and paraventricular white matter region in SIVD patients using 1H magnetic resonance spectroscopy and diffusion tensor imaging

    1. SIVD patients divided into VaD and VCIND group and normal elderly controls matched in age and gender would be recruited. The quantitative analysis of N-acetylaspartate (NAA), myoinositol (mI), Choline (Cho) and Creatine (Cr) resonance signals in region of interests located in thalamus and paraventricular white matter region would be measured. Ratios of NAA/ Cr, mI/ Cr and Cho/ Cr would be calculated in three groups.
    2. Conventional MRI and DTI scanning were received, FA and MD values of white matter in the same bilateral regions would be measured respectively.
    3. These diffusion measurements would be compared across the 3 groups, and significant differences would be further performed for correlation with tests of comprehensive cognitive function.
  4. Clinical significance of serum inflammatory markers in SIVD patients

    1. SIVD patients divided into VaD and VCIND group and normal elderly controls matched in age and gender would be recruited. The serum levels of sCD40L, IL-6, hsCRP were detected by enzyme linked immunosorbent assay (ELISA) and fixed time nephelometry methods in all subjects, respectively.
    2. The relationship would be described among these inflammatory factors and WML, cognitive impairment in patients with SIVD.
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

patients with SIVD diagnosed according to the MRI criteria of Erkinjuntti ,25 normal elderly controls matched in age and gender.

Criteria

Inclusion Criteria:

  • Clinical diagnosis of subcortical ischemic vascular disease
  • Must exist cognitive impairment

Exclusion Criteria:

  • serious dementia could not speak , listen and white
  • other diseases which might cause dementia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01418885

Locations
China, Hebei
Yanhongdong
Shijiazhuang, Hebei, China, 050051
Sponsors and Collaborators
Hebei General Hospital
Investigators
Study Director: Peiyuan Lv, Dr Hebei General Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: hebei general hospital, Neurology
ClinicalTrials.gov Identifier: NCT01418885     History of Changes
Other Study ID Numbers: dongyanhong85989995, Hebei general hospital
Study First Received: August 16, 2011
Last Updated: August 16, 2011
Health Authority: China: Ministry of Health

Keywords provided by Hebei General Hospital:
subcortical ischemic vascular disease

Additional relevant MeSH terms:
Cerebrovascular Disorders
Ischemia
Vascular Diseases
Cognition Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Cardiovascular Diseases
Pathologic Processes
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014