Other Generalized Ischemic Cerebrovascular DiseaseNCT01418885
Cognitive Impairment , Neuroimaging and Inflammatory Markers in Patients With Subcortical Ischemic Vascular Disease
An observational study of Other Generalized Ischemic Cerebrovascular Disease, run by Hebei General Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Other Generalized Ischemic Cerebrovascular Disease
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Sep 2010to Dec 2011
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients with SIVD diagnosed according to the MRI criteria of Erkinjuntti ,25 normal elderly controls matched in age and gender.
Who may be able to join
- Clinical diagnosis of subcortical ischemic vascular disease
- Must exist cognitive impairment
Who cannot join
- serious dementia could not speak , listen and white
- other diseases which might cause dementia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Exploration Between Cognitive Impairment and Neuroimaging and Inflammatory Markers in Patients With Subcortical Ischemic Vascular Disease
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.
Read the detailed description
- Contributions of white matter lesions to cognitive impairment in patients with subcortical ischemic vascular disease
- 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.
- 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.
- Correlation analysis and hierarchical multiple regression analysis would be used to examine the relationship between general cognitive function and WML.
- Evaluation of microstructural white matter lesions in patients with subcortical vascular cognitive impairment using diffusion tensor imaging
- 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.
- These diffusion measurements were compared across the 3 groups, and significant differences would be further performed for correlation with tests of comprehensive cognitive function.
- Evaluation of the lesions in thalamus and paraventricular white matter region in SIVD patients using 1H magnetic resonance spectroscopy and diffusion tensor imaging
- 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.
- Conventional MRI and DTI scanning were received, FA and MD values of white matter in the same bilateral regions would be measured respectively.
- 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.
- Clinical significance of serum inflammatory markers in SIVD patients
- 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.
- The relationship would be described among these inflammatory factors and WML, cognitive impairment in patients with SIVD.
- Keywords
- subcortical ischemic vascular disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SIVD,VaD | vascular disease in patients with SIVD | |
| SIVD,VCIND | vascular cognitive impairment no dementia in patients with SIVD | |
| normal controls | normal elderly controls |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2011 (estimated)
- Study startSep 2010
- Primary completionSep 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Other Generalized Ischemic Cerebrovascular DiseaseStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Peiyuan Lv, Dr, Study director, Hebei General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01418885
- Sponsor's protocol ID
- dongyanhong85989995
- Other IDs
- Hebei general hospital
- Status last verified
- Aug 2010
- First submitted
- 16 Aug 2011
- Last updated
- 17 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Exploration Between Cognitive Impairment and Neuroimaging and Inflammatory Markers in Patients With Subcortical Ischemic Vascular Disease
- ClinicalTrials.gov ID
- NCT01418885
- Acronym / sponsor ID
- dongyanhong85989995
- Keywords
- subcortical ischemic vascular disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hebei General HospitalUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 17 Aug 2011 (estimated)
- 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.
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.
Detailed description
- Contributions of white matter lesions to cognitive impairment in patients with subcortical ischemic vascular disease
- 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.
- 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.
- Correlation analysis and hierarchical multiple regression analysis would be used to examine the relationship between general cognitive function and WML.
- Evaluation of microstructural white matter lesions in patients with subcortical vascular cognitive impairment using diffusion tensor imaging
- 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.
- These diffusion measurements were compared across the 3 groups, and significant differences would be further performed for correlation with tests of comprehensive cognitive function.
- Evaluation of the lesions in thalamus and paraventricular white matter region in SIVD patients using 1H magnetic resonance spectroscopy and diffusion tensor imaging
- 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.
- Conventional MRI and DTI scanning were received, FA and MD values of white matter in the same bilateral regions would be measured respectively.
- 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.
- Clinical significance of serum inflammatory markers in SIVD patients
- 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.
- The relationship would be described among these inflammatory factors and WML, cognitive impairment in patients with SIVD.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SIVD,VaD | – | –vascular disease in patients with SIVD |
| SIVD,VCIND | – | –vascular cognitive impairment no dementia in patients with SIVD |
| normal controls | – | –normal elderly controls |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients with SIVD diagnosed according to the MRI criteria of Erkinjuntti ,25 normal elderly controls matched in age and gender.
Key inclusion criteria (2 listed)
- Clinical diagnosis of subcortical ischemic vascular disease
- Must exist cognitive impairment
Key exclusion criteria (2 listed)
- serious dementia could not speak , listen and white
- other diseases which might cause dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2011.
- Links to Hebei general hospital web pages .Link provided by the sponsor.
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.
Peiyuan Lv, Dr study director
Hebei General 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 Other Generalized Ischemic Cerebrovascular Disease, run by Hebei General Hospital 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 2 inclusion and 2 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 17 Aug 2011. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 17 Aug 2011.