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

NCT ID: NCT05594966

Last Updated: 2022-10-26

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 211 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-11-30
• Study Completion Date: 2025-08-31

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cerebral Small Vessel Disease

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

multimodal MRI

Intervention Type: DIAGNOSTIC_TEST

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.

multimodal MRI

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

multimodal MRI

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Peiying Li

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Li Peiying, MD

Role: PRINCIPAL_INVESTIGATOR

chief professor of Anesthesiology Departmetn,Renji Hospital

Locations

Renji Hospital, Shanghai Jiao Tong University, School of Medicine

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Jin Xia, PD

Role: CONTACT

jinxia026779@renji.com

18094575236 ext. 86

Huang Dan, MS

Role: CONTACT

huangdan@renji.com

15921108822 ext. 86

Facility Contacts

DAN HUANG, MS

Role: primary

huangdan363@163.com

+8615921108822

XIA JIN, PD

Role: backup

jinxia026779@renji.com

+8618094575236

References

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.

Reference Type: RESULT

PMID: 31097385 (View on PubMed)

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.

Reference Type: RESULT

PMID: 23867200 (View on PubMed)

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.

Reference Type: RESULT

PMID: 23426334 (View on PubMed)

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.

Reference Type: RESULT

PMID: 22762316 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26139023 (View on PubMed)

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.

Reference Type: RESULT

PMID: 32682483 (View on PubMed)

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.

Reference Type: RESULT

PMID: 34573867 (View on PubMed)

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.

Reference Type: RESULT

PMID: 28810719 (View on PubMed)

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.

Reference Type: RESULT

PMID: 34631420 (View on PubMed)

Other Identifiers

NeuroIDEA

Identifier Type: -

Identifier Source: org_study_id