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

• Conditions: Leukoaraiosis

• Registration Number: NCT03246373
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-08-03
• Study First Submitted QC: 2017-08-08
• Study First Posted: 2017-08-11
• Study Start: 2017-10-11
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-01
• Last Update Posted: 2020-07-07
• Primary Completion: 2020-12-30
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1037

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
change in cognitive assessment scale score	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

neurology department of Zhongshan hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China