Investigating the link between brain vessel disease and hidden strokes in older patients undergoing surgery
A Multicenter Prospective Cohort Study of Multimodal MRI in Cerebral Small Vessel Disease and Covert Stroke in Perioperative Patients
This study is testing if brain vessel disease in older patients can lead to hidden strokes after surgery and how that might affect their thinking and memory.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 548 (estimated) |
| Ages | 65 Years to 85 Years |
| Sex | All |
| Sponsor | RenJi Hospital Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT04443933 on ClinicalTrials.gov |
What this trial studies
The MOCSS study is a multicenter prospective clinical cohort investigation aimed at understanding the relationship between preoperative cerebral small vessel disease (CSVD) and the occurrence of covert strokes following non-cardiac surgeries in elderly patients. Utilizing multimodal MRI, the study will diagnose CSVD and covert strokes, while also exploring their potential connections to postoperative cognitive dysfunction and delirium. Patients aged 65 to 85 scheduled for elective surgeries will be monitored for various outcomes, including cognitive and physical function over a year post-surgery.
Who should consider this trial
Good fit: Ideal candidates are elderly patients aged 65 to 85 who are scheduled for their first elective non-cardiac surgery.
Not a fit: Patients with pre-existing severe cognitive impairments or other significant brain diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify at-risk patients and improve postoperative care to reduce cognitive decline and complications.
How similar studies have performed: While the specific correlation between CSVD and covert stroke in this context is novel, related studies have indicated that understanding these relationships can lead to better management of postoperative outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Shanghai
- Renji Hospital, Shanghai Jiaotong University School of Medicine — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Peiying Li, MD,PhD
- Email: peiyingli.md@gmail.com
- Phone: 8615800616866
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.