Cerebral Small Vessel DiseasesNCT05359588
Functional Prognosis of Post-operative Patients With Cerebral Small Vascular Disease(CSVD)
An observational study of Cerebral Small Vessel Diseases and Long Term Adverse Effects, run by RenJi Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Cerebral Small Vessel Diseases, Long Term Adverse Effects
- How many people
- 212 participants
- Where
- 1 siteChina
- Study dates
- 31 Jan 2022to 31 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
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
Who may be able to join
- 65≤age<85
- after thoracic surgery
- finish pre-operative brain MRI
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renji Hospital, Shanghai Jiao Tong University, School of Medicine
Shanghai, Shanghai Municipality, 200127
DAN HUANG, MS, +8615921108822, huangdan363@163.com
DAN HUANG, MS
About this study
Official title: 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.
- Medical subject headings
- Cerebral Small Vessel Diseases, Long Term Adverse Effects
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative overt stroke
Postoperative overt stroke detected by MRI of the brain
Measured: 1 year after surgery
Secondary outcomes (2)
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)
Measured: 1 year after surgery
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.
Measured: 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start31 Jan 2022
- Primary completion31 Jan 2023 (estimated)
- Study completion31 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Small Vessel DiseasesStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 212 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05359588
- Sponsor's protocol ID
- CSVD2021
- Status last verified
- Apr 2022
- First submitted
- 29 Jan 2022
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Postoperative Cerebral Vascular Complication and Functional Prognosis and Cerebral Small Vascular Disease (CSVD) After Thoracic Surgery : an Exploratory Study
- ClinicalTrials.gov ID
- NCT05359588
- Acronym / sponsor ID
- CSVD2021
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 31 Jan 2022 (actual)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 4 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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
Key inclusion criteria (3 listed)
- 65≤age<85
- after thoracic surgery
- finish pre-operative brain MRI
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of postoperative overt stroke
Time frame: 1 year after surgery
Postoperative overt stroke detected by MRI of the brain
2 secondary outcomes
Physical function after surgery as assessed using Activities of Daily Living (iADL) Scale
Time frame: 1 year after surgery
Physical function after surgery as assessed using the Modified Rankin Scale
Time frame: 1 year after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Small Vessel Diseases and Long Term Adverse Effects, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dan Huang (+8615921108822, huangdan@renji.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative overt stroke (time frame: 1 year after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2022.