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

April 28, 2022 updated by: RenJi Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

212

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Recruiting
        • Renji Hospital, Shanghai Jiao Tong University, School of Medicine
        • Contact:
        • Principal Investigator:
          • DAN HUANG, MS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 85 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

all postoperative patients between 65 and 85 years old with pre-operative brain MRI results in Renji Hospital Affiliated to Shanghai Jiaotong University from November 2020 to December 2021 after thoracic surgery

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of postoperative overt stroke
Time Frame: 1 year after surgery
Postoperative overt stroke detected by MRI of the brain
1 year after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical function after surgery as assessed using Activities of Daily Living (iADL) Scale
Time Frame: 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)
1 year after surgery
Physical function after surgery as assessed using the Modified Rankin Scale
Time Frame: 1 year after surgery
The scale runs from 0-6, running from perfect health without symptoms to death. A higher score is worse.
1 year after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2022

Primary Completion (Anticipated)

January 31, 2023

Study Completion (Anticipated)

January 31, 2023

Study Registration Dates

First Submitted

January 29, 2022

First Submitted That Met QC Criteria

April 28, 2022

First Posted (Actual)

May 4, 2022

Study Record Updates

Last Update Posted (Actual)

May 4, 2022

Last Update Submitted That Met QC Criteria

April 28, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSVD2021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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