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

Cerebral Small Vessel Diseases Clinical Trial

Official title:

Association Between Postoperative Cerebral Vascular Complication and Functional Prognosis and Cerebral Small Vascular Disease (CSVD) After Thoracic Surgery : an Exploratory Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05359588
• Other study ID #: CSVD2021
• Status: Recruiting
• Start date: January 31, 2022
• Est. completion date: January 31, 2023

Study information

• Verified date: April 2022
• Source: RenJi Hospital
• Contact: Dan Huang
• Phone: +8615921108822
• Email: huangdan[@]renji.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 212
• Est. completion date: January 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Small Vessel Diseases
• Long Term Adverse Effects
• Vascular Diseases

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of postoperative overt stroke	Postoperative overt stroke detected by MRI of the brain	1 year after surgery
Secondary	Physical function after surgery as assessed using Activities of Daily Living (iADL) Scale	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)	1 year after surgery
Secondary	Physical function after surgery as assessed using the Modified Rankin Scale	The scale runs from 0-6, running from perfect health without symptoms to death. A higher score is worse.	1 year after surgery