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

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.

Study Overview

• Status: Unknown
• Conditions: Leukoaraiosis

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 Type: Observational
• Enrollment (Anticipated): 1037

Contacts and Locations

• Study Contact: Name: Anyan Ge; Phone Number: 2976 862164041990; Email: ge.anyan@zs-hospital.sh.cn
• Study Contact Backup: Name: Jing Ding; Phone Number: 12119 8664041990

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • neurology department of Zhongshan hospital, Fudan University
      • Contact: Anyan Ge; Phone Number: 8664041990; Email: ge.anyan@zs-hospital.sh.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Inpatients of physical exmination department or out-patients of neurology department in Zhongshan hospital Fudan University.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in mood assessment Scale score	It will be assessed by Hamilton Depression Scale (HAMD). It is scored 0-30.	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.	baseline and one year
stroke	The participant is diagnosed with stroke	baseline and one year

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Investigators: Principal Investigator: Xin Wang, neurology department of Zhongshan hospital, Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2017
• Primary Completion (Anticipated): December 30, 2020
• Study Completion (Anticipated): December 30, 2020

Study Registration Dates

• First Submitted: August 3, 2017
• First Submitted That Met QC Criteria: August 8, 2017
• First Posted (Actual): August 11, 2017

Study Record Updates

• Last Update Posted (Actual): July 7, 2020
• Last Update Submitted That Met QC Criteria: July 1, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: cognitive impairment
• Additional Relevant MeSH Terms: Pathologic Processes; Leukoaraiosis
• Other Study ID Numbers: CSA2016KY001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No