NCT03246373

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,037

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 11, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

October 11, 2017

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

July 7, 2020

Status Verified

July 1, 2020

Enrollment Period

3.2 years

First QC Date

August 3, 2017

Last Update Submit

July 1, 2020

Conditions

Keywords

cognitive impairment

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • change in mood assessment Scale score

    baseline and one year

  • change in gait evaluation score

    baseline and one year

  • stroke

    baseline and one year

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Physical Examinees or out-patients
  • The MRI scale score ≥ 2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

neurology department of Zhongshan hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood sample fingernail sample hair sample urinary sample

MeSH Terms

Conditions

LeukoaraiosisCognitive Dysfunction

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Xin Wang

    neurology department of Zhongshan hospital, Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2017

First Posted

August 11, 2017

Study Start

October 11, 2017

Primary Completion

December 30, 2020

Study Completion

December 30, 2020

Last Updated

July 7, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations