NCT03544801

Brief Summary

We aim to make clear the impact with the mechanisms of variant pathological injuries on the outcomes of CSVD, to find independent imaging markers and establish prediction model of it.

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
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2015

Longer than P75 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

Study Start

First participant enrolled

September 29, 2015

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

May 31, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 4, 2018

Completed
2.6 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

June 4, 2018

Status Verified

May 1, 2018

Enrollment Period

5.3 years

First QC Date

May 31, 2018

Last Update Submit

May 31, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • a predictive model

    The occurrence, development and predictive imaging markers of cognitive impairment and overall outcomes in post stroke patients with cerebral small vessel diseases.

    2015,July---

Study Arms (2)

sample group ,300

CSVD patients after symptomatic stroke

control group,100

community population

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

longitudinal cohort of post stroke CSVD patients

You may qualify if:

  • ①50-85 years; ② at least 6 years of education; ③ CSVD was defined as patients experienced a clinical lacunar stroke at least 1 months ago, and MRI showed responsible lacunar infarcts and white matter lesions; ④ Cooperate with cognitive tests; ⑤Not accept medications that affect cognition; ⑥. Score of modified Rankin scale ≦3; ⑦. Sign informed consent.

You may not qualify if:

  • ① Etiology due to cardioembolic or large vessel disease (\>50% stenosis in extra- or intra-cerebral arteries); ② Non vasular white matter lesions(WMLs);③ Cortical and/or cortico-subcortical non-lacunar infarct; ④ Other cognitive diseases (such as Alzheimer's disease, Parkinson disease or thyroid disease, etc. ) ⑤Severe systemic diseases such as heart, liver and kidney diseases or major psychiatric disorders; ⑥Severe depressive state: Hamilton depression rating scale score \>24; ⑦ MRI contraindications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renji Hospital,Shanghai Jiao Tong University School of Medicine

Shanghai, 200127, China

RECRUITING

MeSH Terms

Conditions

Cerebrovascular DisordersCognition Disorders

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • qun xu, professor

    RenJi Hospital

    STUDY CHAIR

Central Study Contacts

qun xu, professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2018

First Posted

June 4, 2018

Study Start

September 29, 2015

Primary Completion

December 30, 2020

Study Completion

December 30, 2020

Last Updated

June 4, 2018

Record last verified: 2018-05

Locations