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
NCT number | NCT05359588 |
Other study ID # | CSVD2021 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 31, 2022 |
Est. completion date | January 31, 2023 |
Verified date | April 2022 |
Source | RenJi Hospital |
Contact | Dan Huang |
Phone | +8615921108822 |
huangdan[@]renji.com | |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
China | Renji Hospital, Shanghai Jiao Tong University, School of Medicine | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
RenJi Hospital |
China,
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 |
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