Cerebral Small Vessel Disease and Perioperative Covert Stroke

NCT04443933 | Unknown DMC

• 1 other identifier: KY2019-147
• Study Type: observational
• Target: 548
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cerebral Small Vessel Diseases; Covert Postoperative Stroke

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative covert stroke

  We will use MRI to detect postoperative covert stroke as soon as patients can tolerate MRI.

  14 days

Secondary Outcomes (6)

• Incidence of overt stroke after surgery

  3 months, 6 months and 12 months

• Modified Rankin Scale after surgery

  3 months, 6 months and 12 months

• Cognitive Function assessed by Montreal Cognitive Assessment Scale

  3 months, 6 months and 12 months

• Cognitive Function assessed by Mini-Mental State Examination Scale

  3 months, 6 months and 12 months

• Incidence of delirium

  72 hours

Study Arms (2)

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.

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

5 ml peripheral venous blood samples will be taken before the surgery. The blood samples will be preserved in ethylenediaminetetraacetic acid tubes and patient's information and serial number will be recorded on the tube. Samples are centrifuged for 10min at 2000x g and the supernatants will be transformed into Eppendorf tubes and stored at -80 °C. DNA will be extracted according to the protocol. The DNA samples will be stored at -80°C until further use. Before taking blood from patients, the purpose of using blood samples will be fully explained to them and informed consent will be obtained.

MeSH Terms

Conditions

Cerebral Small Vessel Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Peiying Li, MD,PhD

CONTACT

8615800616866; peiyingli.md@gmail.com

Dan Huang, MD

CONTACT

862168383702; huangdan363@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2020
• First Posted: June 23, 2020
• Study Start: August 1, 2020
• Primary Completion: August 1, 2023
• Study Completion: December 1, 2023
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: All the IPD and any additional supporting information will become available starting 6 months after publication for at least 5 years.
• Access Criteria: Requests to access all the IPD and additional supporting information will be addressed and reviewed by the corresponding author of the related publication. Access criteria include that the requests shall be submitted by a researcher on an institutional headed paper; the requests shall come with all the detailed contact information of the researcher and the administration office of the institution.

Locations

CN (1)