LeukoaraiosisNCT03246373
the Effects of Cerebral Collateral Circulation on the Outcome of Leukoaraiosis in High-risk Population
An observational study of Leukoaraiosis, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
This study observed the relationship between cerebral collateral circulation and the prognosis of leukoaraiosis in high-risk population. Cerebral collateral circulation and leukoaraiosis levels will be evaluated and followed up by magnetic resonance examination. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Leukoaraiosis
- How many people
- 1,037 participants
- Where
- 1 siteChina
- Study dates
- 11 Oct 2017to 30 Dec 2020
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Inpatients of physical exmination department or out-patients of neurology department in Zhongshan hospital Fudan University.
Who may be able to join
- Physical Examinees or out-patients
- The MRI scale score ≥ 2
Who cannot join
- History of stroke
- History of malignant tumor
- History of connective tissue disease
- Pregnant, trying to become pregnant or within 6 weeks after delivery
- serious infections
Trial locations and contacts
1 site in 1 country.
Jing Ding contact
China1 site, 1 recruiting
- Recruiting
neurology department of Zhongshan hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Anyan Ge, 8664041990, ge.anyan@zs-hospital.sh.cn
About this study
Official title: Prospective, Single Center, Observational, Clinical Trial of the Effects of Cerebral Collateral Circulation on the Outcome of Leukoaraiosis in High-risk Population
This study observed the relationship between cerebral collateral circulation and the prognosis of leukoaraiosis in high-risk population. Cerebral collateral circulation and leukoaraiosis levels will be evaluated and followed up by magnetic resonance examination. The participants' clinical performance caused by leukoaraiosis will be assessed by a series of scales.
Read the detailed description
- Case collection information is sent daily to clinical trial supervisors.
- The clinical trial team meets once a week to monitor the quality of clinical trials.
- The severity of the leukoaraiosis will be evaluated by a scale. The patients whose score is more than 2 will take additional magnetic resonance examination including magnetic resonance angiography (MRA) and arterial spin labeling (ASL). And their cognitive ability will be evaluated by a series of scales including Mini-Mental State Examination (MMSE) and Montreal cognitive assessment (MoCA) and gait by the short physical performance battery (SPPB). The blood sample will be taken for biochemical detection and hair and nail samples for trace element detection.
- Data were analyzed by regression analysis.
- Conditions
- Leukoaraiosis
- Keywords
- cognitive impairment
- Medical subject headings
- Leukoaraiosis, Cognitive Dysfunction
What is being measured
The primary outcome is the main question the study is designed to answer.
change in cognitive assessment scale score
It will be assessed by the Mini-Mental state examination (MMSE) and Montreal cognitive assessment (MoCA). Each assessment is scored 0-30, yielding a total between 0-60.
Measured: baseline and one year
Secondary outcomes (3)
change in mood assessment Scale score
It will be assessed by Hamilton Depression Scale (HAMD). It is scored 0-30.
Measured: baseline and one year
change in gait evaluation score
It will be assessed by the short physical performance battery (SPPB). It is scored 0-11.
Measured: baseline and one year
stroke
The participant is diagnosed with stroke
Measured: baseline and one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2017
- Study start11 Oct 2017
- Primary completion30 Dec 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukoaraiosisStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- 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
- 1,037 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xin Wang, Principal investigator, neurology department of Zhongshan hospital, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03246373
- Sponsor's protocol ID
- CSA2016KY001
- Status last verified
- Jul 2020
- First submitted
- 3 Aug 2017
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single Center, Observational, Clinical Trial of the Effects of Cerebral Collateral Circulation on the Outcome of Leukoaraiosis in High-risk Population
- ClinicalTrials.gov ID
- NCT03246373
- Acronym / sponsor ID
- CSA2016KY001
- Conditions
- Leukoaraiosis
- Keywords
- cognitive impairment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,037 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 11 Oct 2017 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 11 Aug 2017 (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.
This study observed the relationship between cerebral collateral circulation and the prognosis of leukoaraiosis in high-risk population. Cerebral collateral circulation and leukoaraiosis levels will be evaluated and followed up by magnetic resonance examination. The participants' clinical performance caused by leukoaraiosis will be assessed by a series of scales.
Detailed description
- Case collection information is sent daily to clinical trial supervisors.
- The clinical trial team meets once a week to monitor the quality of clinical trials.
- The severity of the leukoaraiosis will be evaluated by a scale. The patients whose score is more than 2 will take additional magnetic resonance examination including magnetic resonance angiography (MRA) and arterial spin labeling (ASL). And their cognitive ability will be evaluated by a series of scales including Mini-Mental State Examination (MMSE) and Montreal cognitive assessment (MoCA) and gait by the short physical performance battery (SPPB). The blood sample will be taken for biochemical detection and hair and nail samples for trace element detection.
- Data were analyzed by regression analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inpatients of physical exmination department or out-patients of neurology department in Zhongshan hospital Fudan University.
Key inclusion criteria (2 listed)
- Physical Examinees or out-patients
- The MRI scale score ≥ 2
Key exclusion criteria (5 listed)
- History of stroke
- History of malignant tumor
- History of connective tissue disease
- Pregnant, trying to become pregnant or within 6 weeks after delivery
- serious infections
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
change in cognitive assessment scale score
Time frame: baseline and one year
It will be assessed by the Mini-Mental state examination (MMSE) and Montreal cognitive assessment (MoCA). Each assessment is scored 0-30, yielding a total between 0-60.
3 secondary outcomes
change in mood assessment Scale score
Time frame: baseline and one year
change in gait evaluation score
Time frame: baseline and one year
stroke
Time frame: baseline and one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Individual participant dataSharing planned: No
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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.
Jing Ding contact
Xin Wang principal investigator
neurology department of Zhongshan hospital, Fudan University
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 Leukoaraiosis, run by Shanghai Zhongshan 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 5 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 7 Jul 2020. 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 Anyan Ge (862164041990 ext. 2976, ge.anyan@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in cognitive assessment scale score (time frame: baseline and one year). 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 7 Jul 2020.