Cerebral Small Vessel DiseasesMOCSSNCT04443933
Cerebral Small Vessel Disease and Perioperative Covert Stroke
An observational study of Cerebral Small Vessel Diseases and Covert Postoperative Stroke, run by RenJi Hospital at 1 site in China.
Trial summary
MOCSS study is a multicenter prospective clinical cohort study. The purpose of the MOCSS study is to investigate whether there is a correlation between the preoperative cerebral small vessel disease and the incidence of covert stroke after non-cardiac surgery. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Cerebral Small Vessel Diseases, Covert Postoperative Stroke
- How many people
- 548 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2020to Dec 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: This study will enroll patients aged from 65 to 85 years old who are scheduled for elective non-cardiac surgery and have signed informed consent before the surgery.
Who may be able to join
- Age from 65 years to 85 years;
- The patient is about to have major surgery for the first time and the operation is non-cardiac surgery;
- Written informed consent is obtained before the surgery.
Who cannot join
- mental illness;
- Already have other diseases that can cause dementia, such as Alzheimer's disease, Lewy body dementia, Frontotemporal dementia, progressive supranuclear palsy, Parkinson's disease, Creutzfeldt-Jakob disease, Huntington's disease, alcohol and drug dependence, Neurosyphilis, systemic lupus erythematosus; or preoperative MRI shows hippocampal and temporal lobe atrophy more than two levels, suggesting the possibility of Alzheimer's disease
- Have suffered from other brain diseases (such as stroke, multiple sclerosis, central nervous system infection with sequelae, etc.);
- Preoperative MRI indicates covert stroke
- MMSE or MoCA scale cannot be completed due to other reasons (such as hearing impairment or visual impairment)
- MRI contraindications before or after surgery or patients who cannot tolerate MRI imaging
- Stage 3 or 4 malignant tumors, and high malignancy and poor prognosis cancer, such as pancreatic cancer, gallbladder cancer, and bile duct cancer.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai
Peiying Li, MD,PhD, 8615800616866, peiyingli.md@gmail.com
About this study
Official title: A Multicenter Prospective Cohort Study of Multimodal MRI in Cerebral Small Vessel Disease and Covert Stroke in Perioperative Patients
MOCSS study is a multicenter prospective clinical cohort study. The purpose of the MOCSS study is to investigate whether there is a correlation between the preoperative cerebral small vessel disease and the incidence of covert stroke after non-cardiac surgery. Cerebral small vessel disease (CSVD) and covert stroke will be diagnosed using multimodal MRI. This study will also investigate whether preoperative CSVD and postoperative covert stroke are related to postoperative cognitive dysfunction and delirium.
Read the detailed description
With the growing number of the older population, surgery for elderly patients is on the rise. Elderly patients often have more cardiovascular disease and brain vulnerability and tend to experience more perioperative complications. Perioperative covert stroke is one of those that can been neglected for a long time and is associated with long-term cognitive impairment. While CSVD is an insidious disease mainly affecting small blood vessels in the brain with variable symptoms including dementia, cognitive decline, gait impairment, mood disturbance and stroke. According to the etiopathology of CSVD, there's a possibility that CSVD is a potential risk factor for covert stroke and it may serve as a predictive marker for cognitive decline after surgery.
In this multicenter prospective clinical cohort study, the investigators aim to investigate the correlation between the MRI manifestations of cerebral small vessel disease and perioperative covert stroke.
Patients aged between 65 to 85 who are scheduled for elective non-cardiac surgeries will be enrolled.The primary outcome is the incidence of perioperative covert stroke diagnosed by MRI. Secondary outcomes include incidence of delirium (using ICU-CAM) within 3 days after surgery and cognitive function tests (using Mini-Mental State Examination and Montreal Cognitive Assessment), physical function test (using ADL, Activities of Daily Living) and dependence test (using modified Rankin Scale) at 3 months, 6 months and 12months after surgery.
- Medical subject headings
- Cerebral Small Vessel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cerebral Small Vessel Disease | In this group, patients are diagnosed with cerebral small vessel disease preoperatively using multimodal MRI. | |
| non-Cerebral Small Vessel Disease | In this group, cerebral small vessel disease is ruled out by preoperative multimodal MRI. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative covert stroke
We will use MRI to detect postoperative covert stroke as soon as patients can tolerate MRI.
Measured: 14 days
Secondary outcomes (6)
Incidence of overt stroke after surgery
Incidence of overt stroke will be measured by obtaining medical history.
Measured: 3 months, 6 months and 12 months
Modified Rankin Scale after surgery
The Modified Rankin Scale measures the degree of disability or dependence in the daily activities of people after stroke or other neurological disability.Minimum value:0, Maximum value:6. Higher scores mean a worse outcome.
Measured: 3 months, 6 months and 12 months
Cognitive Function assessed by Montreal Cognitive Assessment Scale
We will use Montreal Cognitive Assessment (MoCA) scale to assess cognitive function after surgery. Minimum value:0, Maximum value: 30. Higher scores mean a better outcome.
Measured: 3 months, 6 months and 12 months
Cognitive Function assessed by Mini-Mental State Examination Scale
We will use Mini-Mental State Examination (MMSE) scale to assess cognitive function after surgery. Minimum value:0, Maximum value: 30. Higher scores mean a better outcome.
Measured: 3 months, 6 months and 12 months
Incidence of delirium
Incidence of delirium will be measured using Intensive Care Unit-Cognitive Assessment Method (ICU-CAM) every 12 hours till the 72 hours after surgery.
Measured: 72 hours
Physical functions after surgery
The investigators will use Activities of daily living (ADL) scale to measure physical function after surgery. Minimum value:0, Maximum value: 78. Higher scores mean a better outcome.
Measured: 3 months, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start1 Aug 2020
- Primary completionAug 2023 (estimated)
- Study completionDec 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
- Prospective
- Enrolment
- 548 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
- NCT04443933
- Sponsor's protocol ID
- KY2019-147
- Acronym
- MOCSS
- Status last verified
- Jun 2023
- First submitted
- 14 Jun 2020
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication will be shared starting 6 months after publication.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Cohort Study of Multimodal MRI in Cerebral Small Vessel Disease and Covert Stroke in Perioperative Patients
- ClinicalTrials.gov ID
- NCT04443933
- Acronym / sponsor ID
- MOCSS / KY2019-147
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 548 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 23 Jun 2020 (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.
MOCSS study is a multicenter prospective clinical cohort study. The purpose of the MOCSS study is to investigate whether there is a correlation between the preoperative cerebral small vessel disease and the incidence of covert stroke after non-cardiac surgery. Cerebral small vessel disease (CSVD) and covert stroke will be diagnosed using multimodal MRI. This study will also investigate whether preoperative CSVD and postoperative covert stroke are related to postoperative cognitive dysfunction and delirium.
Detailed description
With the growing number of the older population, surgery for elderly patients is on the rise. Elderly patients often have more cardiovascular disease and brain vulnerability and tend to experience more perioperative complications. Perioperative covert stroke is one of those that can been neglected for a long time and is associated with long-term cognitive impairment. While CSVD is an insidious disease mainly affecting small blood vessels in the brain with variable symptoms including dementia, cognitive decline, gait impairment, mood disturbance and stroke. According to the etiopathology of CSVD, there's a possibility that CSVD is a potential risk factor for covert stroke and it may serve as a predictive marker for cognitive decline after surgery.
In this multicenter prospective clinical cohort study, the investigators aim to investigate the correlation between the MRI manifestations of cerebral small vessel disease and perioperative covert stroke.
Patients aged between 65 to 85 who are scheduled for elective non-cardiac surgeries will be enrolled.The primary outcome is the incidence of perioperative covert stroke diagnosed by MRI. Secondary outcomes include incidence of delirium (using ICU-CAM) within 3 days after surgery and cognitive function tests (using Mini-Mental State Examination and Montreal Cognitive Assessment), physical function test (using ADL, Activities of Daily Living) and dependence test (using modified Rankin Scale) at 3 months, 6 months and 12months after surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cerebral Small Vessel Disease | – | –In this group, patients are diagnosed with cerebral small vessel disease preoperatively using multimodal MRI. |
| non-Cerebral Small Vessel Disease | – | –In this group, cerebral small vessel disease is ruled out by preoperative multimodal MRI. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- This study will enroll patients aged from 65 to 85 years old who are scheduled for elective non-cardiac surgery and have signed informed consent before the surgery.
Key inclusion criteria (3 listed)
- Age from 65 years to 85 years;
- The patient is about to have major surgery for the first time and the operation is non-cardiac surgery;
- Written informed consent is obtained before the surgery.
Key exclusion criteria (7 listed)
- mental illness;
- Already have other diseases that can cause dementia, such as Alzheimer's disease, Lewy body dementia, Frontotemporal dementia, progressive supranuclear palsy, Parkinson's disease, Creutzfeldt-Jakob disease, Huntington's disease, alcohol and drug dependence, Neurosyphilis, systemic lupus erythematosus; or preoperative MRI shows hippocampal and temporal lobe atrophy more than two levels, suggesting the possibility of Alzheimer's disease
- Have suffered from other brain diseases (such as stroke, multiple sclerosis, central nervous system infection with sequelae, etc.);
- Preoperative MRI indicates covert stroke
- MMSE or MoCA scale cannot be completed due to other reasons (such as hearing impairment or visual impairment)
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 covert stroke
Time frame: 14 days
We will use MRI to detect postoperative covert stroke as soon as patients can tolerate MRI.
6 secondary outcomes
Incidence of overt stroke after surgery
Time frame: 3 months, 6 months and 12 months
Modified Rankin Scale after surgery
Time frame: 3 months, 6 months and 12 months
Cognitive Function assessed by Montreal Cognitive Assessment Scale
Time frame: 3 months, 6 months and 12 months
Cognitive Function assessed by Mini-Mental State Examination Scale
Time frame: 3 months, 6 months and 12 months
Incidence of delirium
Time frame: 72 hours
Physical functions after surgery
Time frame: 3 months, 6 months and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication will be shared starting 6 months after publication.
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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 Covert Postoperative Stroke, 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 7 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 22 Jun 2023. 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 Peiying Li, MD,PhD (8615800616866, peiyingli.md@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative covert stroke (time frame: 14 days). 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 22 Jun 2023.