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

NCT05594966 | Unknown

• 1 other identifier: NeuroIDEA
• Study Type: observational
• Target: 211
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Cognitive Dysfunction; Postoperative Delirium; Cerebral Small Vessel Diseases; Covert Postoperative Stroke

Outcome Measures

Primary Outcomes (1)

• A medical model to predict the POCD after cardiac surgery.

  A composite model of MRI and biomarker risk factors to predict the incidence of POCD in patients undergoing selective cardiac surgery

  1 year

Secondary Outcomes (1)

• Build a medical model to predict the POD after cardiac surgery.

  5 days

Study Arms (2)

Cerebral Small Vessel Disease

In this group, patients are diagnosed with cerebral small vessel disease preoperatively using multimodal MRI.

Diagnostic Test: 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

Interventions

multimodal MRI DIAGNOSTIC_TEST

patients are diagnosed with cerebral small vessel disease preoperatively using multimodal MRI

Cerebral Small Vessel Disease; non-Cerebral Small Vessel Disease

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Age from 50 years to 85 years;
• The patient is going to have selective 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 three levels
• Have suffered from other brain diseases (such as overt 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 Jiao Tong University, School of Medicine

Shanghai, Shanghai Municipality, 200127, China

Location

Related Publications (9)

• Wardlaw JM, Smith C, Dichgans M. Small vessel disease: mechanisms and clinical implications. Lancet Neurol. 2019 Jul;18(7):684-696. doi: 10.1016/S1474-4422(19)30079-1. Epub 2019 May 13.

  PMID: 31097385 RESULT

• Wardlaw JM, Smith EE, Biessels GJ, Cordonnier C, Fazekas F, Frayne R, Lindley RI, O'Brien JT, Barkhof F, Benavente OR, Black SE, Brayne C, Breteler M, Chabriat H, Decarli C, de Leeuw FE, Doubal F, Duering M, Fox NC, Greenberg S, Hachinski V, Kilimann I, Mok V, Oostenbrugge Rv, Pantoni L, Speck O, Stephan BC, Teipel S, Viswanathan A, Werring D, Chen C, Smith C, van Buchem M, Norrving B, Gorelick PB, Dichgans M; STandards for ReportIng Vascular changes on nEuroimaging (STRIVE v1). Neuroimaging standards for research into small vessel disease and its contribution to ageing and neurodegeneration. Lancet Neurol. 2013 Aug;12(8):822-38. doi: 10.1016/S1474-4422(13)70124-8.

  PMID: 23867200 RESULT

• Guenther U, Theuerkauf N, Frommann I, Brimmers K, Malik R, Stori S, Scheidemann M, Putensen C, Popp J. Predisposing and precipitating factors of delirium after cardiac surgery: a prospective observational cohort study. Ann Surg. 2013 Jun;257(6):1160-7. doi: 10.1097/SLA.0b013e318281b01c.

  PMID: 23426334 RESULT

• Saczynski JS, Marcantonio ER, Quach L, Fong TG, Gross A, Inouye SK, Jones RN. Cognitive trajectories after postoperative delirium. N Engl J Med. 2012 Jul 5;367(1):30-9. doi: 10.1056/NEJMoa1112923.

  PMID: 22762316 RESULT

• Fong TG, Davis D, Growdon ME, Albuquerque A, Inouye SK. The interface between delirium and dementia in elderly adults. Lancet Neurol. 2015 Aug;14(8):823-832. doi: 10.1016/S1474-4422(15)00101-5. Epub 2015 Jun 29.

  PMID: 26139023 RESULT

• Turan A, Duncan A, Leung S, Karimi N, Fang J, Mao G, Hargrave J, Gillinov M, Trombetta C, Ayad S, Hassan M, Feider A, Howard-Quijano K, Ruetzler K, Sessler DI; DECADE Study Group. Dexmedetomidine for reduction of atrial fibrillation and delirium after cardiac surgery (DECADE): a randomised placebo-controlled trial. Lancet. 2020 Jul 18;396(10245):177-185. doi: 10.1016/S0140-6736(20)30631-0.

  PMID: 32682483 RESULT

• Angiulli F, Conti E, Zoia CP, Da Re F, Appollonio I, Ferrarese C, Tremolizzo L. Blood-Based Biomarkers of Neuroinflammation in Alzheimer's Disease: A Central Role for Periphery? Diagnostics (Basel). 2021 Aug 24;11(9):1525. doi: 10.3390/diagnostics11091525.

  PMID: 34573867 RESULT

• Grotti S, Falsini G. Delirium in cardiac patients. Eur Heart J. 2017 Aug 1;38(29):2244. doi: 10.1093/eurheartj/ehx380. No abstract available.

  PMID: 28810719 RESULT

• Muscat SM, Barrientos RM. The Perfect Cytokine Storm: How Peripheral Immune Challenges Impact Brain Plasticity & Memory Function in Aging. Brain Plast. 2021 Aug 23;7(1):47-60. doi: 10.3233/BPL-210127. eCollection 2021.

  PMID: 34631420 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

5 ml peripheral venous blood samples will be taken before and after 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

Postoperative Cognitive Complications; Emergence Delirium; Cerebral Small Vessel Diseases

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Li Peiying, MD

  chief professor of Anesthesiology Departmetn,Renji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jin Xia, PD

CONTACT

18094575236; jinxia026779@renji.com

Huang Dan, MS

CONTACT

15921108822; huangdan@renji.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 23, 2022
• First Posted: October 26, 2022
• Study Start: November 1, 2022
• Primary Completion: March 1, 2025
• Study Completion: August 1, 2025
• Last Updated: October 26, 2022

Record last verified: 2022-10

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)