Postoperative Cognitive DysfunctionNeuroIDEANCT05594966
Neuroimaging Combining Biomarkers for Identifying Long-term Cognitive Dysfunction and Delirium
An observational study of Postoperative Cognitive Dysfunction and Postoperative Delirium, run by RenJi Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Postoperative Cognitive Dysfunction, Postoperative Delirium, Cerebral Small Vessel Diseases
- What is being tested?
- multimodal MRI
- How many people
- 211 participants
- Where
- 1 siteChina
- Study dates
- Nov 2022to Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Age from 50 years to 85 years;
- The patient is going to have selective cardiac surgery;
- Written informed consent is obtained before the surgery.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Renji Hospital, Shanghai Jiao Tong University, School of Medicine
Shanghai, Shanghai Municipality, 200127
DAN HUANG, MS, +8615921108822, huangdan363@163.com
XIA JIN, PD, +8618094575236, jinxia026779@renji.com
About this study
Official title: 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.
Read the 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
- Being tested
- multimodal MRI
- Medical subject headings
- Postoperative Cognitive Complications, Emergence Delirium, Cerebral Small Vessel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multimodal MRIDiagnostic test
patients are diagnosed with cerebral small vessel disease preoperatively using multimodal MRI
| Study group | Role | What they receive |
|---|---|---|
| Cerebral Small Vessel Disease | In this group, patients are diagnosed with cerebral small vessel disease preoperatively using multimodal MRI. Receives: Diagnostic Test: multimodal MRI | |
| non-Cerebral Small Vessel Disease | In this group, cerebral small vessel disease is ruled out by preoperative multimodal MRI. Receives: Diagnostic Test: multimodal MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (1)
Build a medical model to predict the POD after cardiac surgery.
A composite model of MRI and biomarker risk factors to predict the incidence of POD in patients undergoing selective cardiac surgery
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study startNov 2022 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Postoperative Cognitive DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 211 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peiying Li, RenJi Hospital
- Investigators
- Li Peiying, MD, Principal investigator, chief professor of Anesthesiology Departmetn,Renji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05594966
- Sponsor's protocol ID
- NeuroIDEA
- Acronym
- NeuroIDEA
- Status last verified
- Oct 2022
- First submitted
- 23 Oct 2022
- Last updated
- 26 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication will be shared starting 6 months after publication.
Publications
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.
PubMed 31097385Wardlaw 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.
PubMed 23867200Guenther 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.
PubMed 23426334Saczynski 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.
PubMed 22762316Fong 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.
PubMed 26139023Turan 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.
PubMed 32682483Angiulli 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.
PubMed 34573867Grotti S, Falsini G. Delirium in cardiac patients. Eur Heart J. 2017 Aug 1;38(29):2244. doi: 10.1093/eurheartj/ehx380. No abstract available.
PubMed 28810719Muscat 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.
PubMed 34631420
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroimaging Combining Biomarkers for Identifying Long-term Cognitive Dysfunction and Delirium After Cardiac Surgery Early and Availably
- ClinicalTrials.gov ID
- NCT05594966
- Acronym / sponsor ID
- NeuroIDEA / NeuroIDEA
- Conditions
- Postoperative Cognitive Dysfunction, Postoperative Delirium, Cerebral Small Vessel Diseases, Covert Postoperative Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 211 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- Nov 2022 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 26 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cerebral Small Vessel Disease | – | Diagnostic Test: multimodal MRIIn this group, patients are diagnosed with cerebral small vessel disease preoperatively using multimodal MRI. |
| non-Cerebral Small Vessel Disease | – | Diagnostic Test: multimodal MRIIn this group, cerebral small vessel disease is ruled out by preoperative multimodal MRI. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- Age from 50 years to 85 years;
- The patient is going to have selective cardiac surgery;
- Written informed consent is obtained before the surgery.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multimodal MRIpatients are diagnosed with cerebral small vessel disease preoperatively using multimodal MRI | Diagnostic test | Cerebral Small Vessel Disease, non-Cerebral Small Vessel Disease |
Primary outcome
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 secondary outcome
Build a medical model to predict the POD after cardiac surgery.
Time frame: 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Results publication: PubMed 31097385Wardlaw 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.
- Results publication: PubMed 23867200Wardlaw 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.
- Results publication: PubMed 23426334Guenther 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.
- Results publication: PubMed 22762316Saczynski 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.
- Results publication: PubMed 26139023Fong 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.
- Results publication: PubMed 32682483Turan 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.
- Results publication: PubMed 34573867Angiulli 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.
- Results publication: PubMed 28810719Grotti S, Falsini G. Delirium in cardiac patients. Eur Heart J. 2017 Aug 1;38(29):2244. doi: 10.1093/eurheartj/ehx380. No abstract available.
- Results publication: PubMed 34631420Muscat 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.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication will be shared starting 6 months after publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Peiying, MD principal investigator
chief professor of Anesthesiology Departmetn,Renji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Cognitive Dysfunction and Postoperative Delirium, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jin Xia, PD (18094575236 ext. 86, jinxia026779@renji.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A medical model to predict the POCD after cardiac surgery. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05594966, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2022.