Functional Prognosis of Post-operative Patients With Cerebral Small Vascular Disease(CSVD)

• Conditions: Long Term Adverse Effects; Cerebral Small Vessel Diseases

• Registration Number: NCT05359588
• Lead Sponsor: RenJi Hospital

Brief Summary

The investigators perform a retro-prospective exploratory cohort study among patients 65 to 85 years old with pre-operative head MRI result after thoracic surgery in Renji Hospital Affiliated to Shanghai Jiaotong University from November 2020 to December 2021. Perioperative data were collected, including preoperative general condition, laboratory examination, auxiliary examination (blood routine, blood coagulation, liver and kidney function, etc.), perioperative indicators （use of anesthetics, anesthetic time, blood pressure, etc.）, postoperative cerebral function follow-up and occurrence of cerebral vascular complications (brain infarction, brain bleed, etc.) of patients.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-29
• Study Start: 2022-01-31
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-28
• Last Update Submitted: 2022-04-28
• Study First Posted: 2022-05-04
• Last Update Posted: 2022-05-04
• Primary Completion: 2023-01-31
• Study Completion: 2023-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 212

Inclusion Criteria

• 65≤age<85
• after thoracic surgery
• finish pre-operative brain MRI

Exclusion Criteria

• mental illness
• existing dementia and other diseases: Alzheimer disease, dementia, Parkinson's disease, Huntington's disease, systemic lupus erythematosus, etc.
• previous cerebral infarction or hemorrhage

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of postoperative overt stroke	1 year after surgery	Postoperative overt stroke detected by MRI of the brain

Secondary Outcome Measures

Name	Time	Method
Physical function after surgery as assessed using Activities of Daily Living (iADL) Scale	1 year after surgery	score of Activity of Daily Living Scale with total score of 78, higher score, better function) and Modified Ranking Scale from 0(no symptomatic post-infarction complication ) to 6 (death after cerebral infaction)
Physical function after surgery as assessed using the Modified Rankin Scale	1 year after surgery	The scale runs from 0-6, running from perfect health without symptoms to death. A higher score is worse.

Trial Locations

Locations (1)

Renji Hospital, Shanghai Jiao Tong University, School of Medicine; 🇨🇳 Shanghai, Shanghai, China