NCT05359588

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
212

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

January 31, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 4, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

May 4, 2022

Status Verified

April 1, 2022

Enrollment Period

1 year

First QC Date

January 29, 2022

Last Update Submit

April 28, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidence of postoperative overt stroke

    Postoperative overt stroke detected by MRI of the brain

    1 year after surgery

Secondary Outcomes (2)

  • Physical function after surgery as assessed using Activities of Daily Living (iADL) Scale

    1 year after surgery

  • Physical function after surgery as assessed using the Modified Rankin Scale

    1 year after surgery

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renji Hospital, Shanghai Jiao Tong University, School of Medicine

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

MeSH Terms

Conditions

Cerebral Small Vessel DiseasesLong Term Adverse Effects

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2022

First Posted

May 4, 2022

Study Start

January 31, 2022

Primary Completion

January 31, 2023

Study Completion

January 31, 2023

Last Updated

May 4, 2022

Record last verified: 2022-04

Locations