Renji Cerebral Small Vessel Disease Corhort Study

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03544801

Acronym

RCCS

Enrollment

300

Registered

2018-06-04

Start date

2015-09-29

Completion date

2020-12-30

Last updated

2018-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebrovascular Disorders, Cognition Disorders

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.

Detailed description

A cohort of post stroke cerebral small vessel disease (CSVD) patients with different cognitive status are consecutively recruited in this study. Detailed full domain cognitive assessment and multi-modal MRI (including brain morphology , DTI indices, microbleed counts, brain volumes as well as brain network characters, etc.) are performed. Cognitive states(including attention-executive function, memory, language, visuo-spatial and global cognition with the transition to dementia) and the overall prognosis (cardiovascular events, stroke recurrence, death due to cardiovascular event and all cause death) are longitudinally followed up. The correlations between baseline and followed MRI parameters with the outcomes are analyzed in order 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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

50 Years to 85 Years

Healthy volunteers

Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame	Description
a predictive model	2015,July---	The occurrence, development and predictive imaging markers of cognitive impairment and overall outcomes in post stroke patients with cerebral small vessel diseases.

Countries

China

Contacts

Primary Contactqun xu, professor

xuqun628@163.com13301679717

Outcome results