the Effects of Cerebral Collateral Circulation on the Outcome of Leukoaraiosis in High-risk Population

Leukoaraiosis Clinical Trial

Official title:

Prospective, Single Center, Observational, Clinical Trial of the Effects of Cerebral Collateral Circulation on the Outcome of Leukoaraiosis in High-risk Population

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03246373
• Other study ID #: CSA2016KY001
• Status: Recruiting
• Start date: October 11, 2017
• Est. completion date: December 30, 2020

Study information

• Verified date: July 2020
• Source: Shanghai Zhongshan Hospital
• Contact: Anyan Ge
• Phone: 862164041990
• Email: ge.anyan[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. The participants' clinical performance caused by leukoaraiosis will be assessed by a series of scales.

Description:

1. Case collection information is sent daily to clinical trial supervisors.

2. The clinical trial team meets once a week to monitor the quality of clinical trials.

3. 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.

4. Data were analyzed by regression analysis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1037
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• Physical Examinees or out-patients

• The MRI scale score = 2

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Leukoaraiosis

Locations

Country	Name	City	State
China	neurology department of Zhongshan hospital, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline and one year
Secondary	change in mood assessment Scale score	It will be assessed by Hamilton Depression Scale (HAMD). It is scored 0-30.	baseline and one year
Secondary	change in gait evaluation score	It will be assessed by the short physical performance battery (SPPB). It is scored 0-11.	baseline and one year
Secondary	stroke	The participant is diagnosed with stroke	baseline and one year