Neuroimaging Combining Biomarkers for Identifying Long-term Cognitive Dysfunction and Delirium

Not yet recruiting

• Conditions: Covert Postoperative Stroke; Postoperative Cognitive Dysfunction; Postoperative Delirium; Cerebral Small Vessel Diseases
• Interventions: Diagnostic Test: multimodal MRI

• Registration Number: NCT05594966
• Lead Sponsor: RenJi Hospital

Brief Summary

Postoperative Cognitive Dysfunction(POCD) is commonly seen in cardiac surgery, which may lead to poor pognosis. Cerebral small vessel disease(CVSD) is refer as the main resource of delirium among elderly people. In the study, CVSD will be diagnosed using multimodal MRI. And we want to select a high correlating COPD biomarker through CyTOF. We also want to investigate a medical model to select the high risk patients who may suffer from POCD after cardiac surgery.

Detailed Description

This study will investigate whether preoperative CSVD and CyTOF will help to predict the occurencce of Postoprative Cognitive Dysfunction(POCD) in 1 year after surgery. The investigators perform a prospective cohort study among selective cardiac surgery patients between 50 to 85 years old. All participates have pre-operative head multimodel MRI in Renji Hospital Affiliated to Shanghai Jiaotong University. Incusion and exclusion criteria and relevant data were collected. Patients' age, gender, specific surgical methods, educational background, BMI, tobacco and alcohol history, and systematic medical history were collected before surgery, specific history (heart disease, heart failure, arrhythmia, cornoary artery stent implantation, and history of cardiac surgery), medical history (blood pressure medication, anti-arrhythmic drugs, diuresis, anti-arrhythemic drugs, diuresis, anticoagulant drugs), laboratory examination, auxiliary examination(blood routine, blood coagulation, liver and kidney function, etc.), and Cognitive Function Assessment Scale(MMSE, MOCA, ADL, GDSS). Perioperative indicators were also collected, including use of anesthetics, anestetic time,vital signs, etc. Blood sample should be taken before and after surgery. Postopeative data including: POD whithin 5 days after surgery, cardiovascular drugs use in ICU, mechanical ventilation time, length of stay in ICU, occurrence of complicatiosns of patients, Cognitive function Assessment Scale 1 year after surgery. POD was assessed by a professionally trained clinician twice daily at 8-12 hour intervals, using CAM-ICU scale, if diagnosis with POD, DRS-98 is used to evaluate th severity of POD. POCD was assessed by a professionally trained clinican at 1 year after surgery. The incidence of POD and POCD was analyzed between groups, and the association between each index and delirium and POCD was analyzed by logistic regresssion. The waste blood from routine peripheral blood examination was collected before operation, at the end of operation, on the second day after operation and one year after opertion for the detection of biomarkers by CyTOF, and the composite model of MRI and biomarkers was established.

Study Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-10-23
• Study First Submitted QC: 2022-10-23
• Last Update Submitted: 2022-10-23
• Study First Posted: 2022-10-26
• Last Update Posted: 2022-10-26
• Study Start: 2022-11
• Primary Completion: 2025-03
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 211

Inclusion Criteria

1. Age from 50 years to 85 years;
2. The patient is going to have selective cardiac surgery;
3. Written informed consent is obtained before the surgery.

Exclusion Criteria

1. mental illness;
2. 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 three levels
3. Have suffered from other brain diseases (such as overt stroke, multiple sclerosis, central nervous system infection with sequelae, etc.);
4. Preoperative MRI indicates covert stroke MMSE or MoCA scale cannot be completed due to other reasons (such as hearing impairment or visual impairment)
5. MRI contraindications before or after surgery or patients who cannot tolerate MRI imaging
6. Stage 3 or 4 malignant tumors, and high malignancy and poor prognosis cancer, such as pancreatic cancer, gallbladder cancer, and bile duct cancer.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cerebral Small Vessel Disease	multimodal MRI	In this group, patients are diagnosed with cerebral small vessel disease preoperatively using multimodal MRI.
non-Cerebral Small Vessel Disease	multimodal MRI	In this group, cerebral small vessel disease is ruled out by preoperative multimodal MRI.

Primary Outcome Measures

Name	Time	Method
A medical model to predict the POCD after cardiac surgery.	1 year	A composite model of MRI and biomarker risk factors to predict the incidence of POCD in patients undergoing selective cardiac surgery

Secondary Outcome Measures

Name	Time	Method
Build a medical model to predict the POD after cardiac surgery.	5 days	A composite model of MRI and biomarker risk factors to predict the incidence of POD in patients undergoing selective cardiac surgery

Trial Locations

Locations (1)

Renji Hospital, Shanghai Jiao Tong University, School of Medicine; 🇨🇳 Shanghai, Shanghai, China