Renji Cerebral Small Vessel Disease Corhort Study

Cerebrovascular Disorders Clinical Trial

— RCCS  

Official title:

Renji Cerebral Small Vessel Disease Corhort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03544801
• Other study ID #: [2013012]
• Status: Recruiting
• Start date: September 29, 2015
• Est. completion date: December 30, 2020

Study information

• Verified date: May 2018
• Source: RenJi Hospital
• Contact: qun xu, professor
• Phone: 13301679717
• Email: xuqun628[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

Inclusion Criteria:

• ?50-85 years; ? at least 6 years of education; ? 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; ? Cooperate with cognitive tests; ?Not accept medications that affect cognition; ?. Score of modified Rankin scale ?3; ?. Sign informed consent.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Cerebral Small Vessel Diseases
• Cerebrovascular Disorders
• Cognition Disorders
• Disease

Locations

Country	Name	City	State
China	Renji Hospital,Shanghai Jiao Tong University School of Medicine	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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---