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

October 23, 2022 updated by: Peiying Li, RenJi Hospital

Neuroimaging Combining Biomarkers for Identifying Long-term Cognitive Dysfunction and Delirium After Cardiac Surgery Early and Availably

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

211

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Renji Hospital, Shanghai Jiao Tong University, School of Medicine
        • Contact:
        • Contact:
        • Principal Investigator:
          • DAN HUANG, MS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The incidence of POCD after cardiac surgery varies greatly in different studies. Accroding to JAMA and Lancet papers, the incidence of POCD in patients one year after cardiac surgeries is 20-31%. According to the Events per Variable method, the main objective model establishment will explore 5 Events of independent variables. Assuming EPV is 10, the incidence of POCD is 26%, so the number of POCD patients after surgeries should be 5*10=50. Take 10% loss of follow-up rate into account, the total sample size required is 50/26%*110%=211

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cerebral Small Vessel Disease
In this group, patients are diagnosed with cerebral small vessel disease preoperatively using multimodal MRI.
Diagnostic test: multimodal MRI
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.
Diagnostic test: multimodal MRI
patients are diagnosed with cerebral small vessel disease preoperatively using multimodal MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A medical model to predict the POCD after cardiac surgery.
Time Frame: 1 year
A composite model of MRI and biomarker risk factors to predict the incidence of POCD in patients undergoing selective cardiac surgery
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Investigators

  • Principal Investigator: Li Peiying, MD, chief professor of Anesthesiology Departmetn,Renji Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2022

Primary Completion (Anticipated)

March 1, 2025

Study Completion (Anticipated)

August 1, 2025

Study Registration Dates

First Submitted

October 23, 2022

First Submitted That Met QC Criteria

October 23, 2022

First Posted (Actual)

October 26, 2022

Study Record Updates

Last Update Posted (Actual)

October 26, 2022

Last Update Submitted That Met QC Criteria

October 23, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NeuroIDEA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

All IPD that underlie results in a publication will be shared starting 6 months after publication.

IPD Sharing Time Frame

All the IPD and any additional supporting information will become available starting 6 months after publication for at least 5 years.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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