Neurocognitive DisorderNCT07878676
Impact of Preoperative Mild Cognitive Impairment on Postoperative Delirium in Patients Undergoing Cardiac Surgery
An observational study of Neurocognitive Disorder and Cardiac Surgery, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
Trial summary
This study is intended to explore the impact of mild cognitive impairment on the incidence of delirium after cardiac surgery in older patients. The main question this study tries to answer is: Does preoperative mild cognitive impairment influence the incidence of postoperative delirium in cardiovascular surgery?… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Neurocognitive Disorder, Cardiac Surgery
- How many people
- 261 participants
- Where
- 1 siteChina
- Study dates
- Oct 2026to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Undergo elective cardiac surgery with cardiopulmonary bypass
Inclusion Criteria: 1) Age≥60 years 2) Elective cardiac surgery with cardiopulmonary bypass 3) Written Informed consent provided -
Exclusion Criteria: 1) deep hypothermia and circulatory arrest; 2) unable to receive neurocognitive evaluation due to language, vision or hearing impairments 3) breastfeeding or pregnancy 4) terminal illness with a life expectancy of less than 3 months 5) mental or legal disability.
-
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College
Beijing, 100037
Jia Shi, 86 10 88322467, shijia@fuwai.com
About this study
This study is intended to explore the impact of mild cognitive impairment on the incidence of delirium after cardiac surgery in older patients. The main question this study tries to answer is: Does preoperative mild cognitive impairment influence the incidence of postoperative delirium in cardiovascular surgery? Participants diagnosed with mild cognitive impairment who are supposed to perform cardiovascular surgery will answer questionnaires about cognitive function after surgery.
- Conditions
- Neurocognitive Disorder, Cardiac Surgery
- Medical subject headings
- Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| MCI | participants who are diagnosed with MCI before surgery | |
| non-MCI | participants with normal cognitive function before surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
the 5-day incidence of postoperative delirium
the incedence of delirium evaluated by CAM/CAM-ICU
Measured: within five days postoperatively
Secondary outcomes (3)
Time to extubation
Time to extubation postoperatively
Measured: Perioperative
Length of stay (LOS) in intensive care unit (ICU)
Length of stay (LOS) in intensive care unit (ICU) postoperatively
Measured: Perioperative
Length of stay (LOS) in hospital
Length of stay (LOS) in hospital postoperatively
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Neurocognitive DisorderStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai HospitalThe sponsor's other registered studies.
- 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
- 261 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SHI Jia, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07878676
- Sponsor's protocol ID
- The MCI study
- Status last verified
- Oct 2026
- First submitted
- 11 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared in order to protect participant privacy and confidentiality.
Publications
Brown CH 4th, Probert J, Healy R, Parish M, Nomura Y, Yamaguchi A, Tian J, Zehr K, Mandal K, Kamath V, Neufeld KJ, Hogue CW. Cognitive Decline after Delirium in Patients Undergoing Cardiac Surgery. Anesthesiology. 2018 Sep;129(3):406-416. doi: 10.1097/ALN.0000000000002253.
PubMed 29771710Srivatsa S, Sujanthan S, Paleczny S, Ripsman DA, de Rivera SN, Dimagli A, Taghdiri F, Cheng PS, Lou W, Farkouh ME, Fremes SE, Gaudino MF, Rabin J, Razzouk L, Owen AM, Creber RM, Swartz RH. Cognitive Outcomes in Randomized Controlled Trials of Coronary Artery Bypass Graft Surgery From 2005 to 2025: A Systematic Review. J Am Heart Assoc. 2026 Jan 20;15(2):e041946. doi: 10.1161/JAHA.125.041946. Epub 2026 Jan 14.
PubMed 41532517Jongsiriyanyong S, Limpawattana P. Mild Cognitive Impairment in Clinical Practice: A Review Article. Am J Alzheimers Dis Other Demen. 2018 Dec;33(8):500-507. doi: 10.1177/1533317518791401. Epub 2018 Aug 1.
PubMed 30068225Hugo J, Ganguli M. Dementia and cognitive impairment: epidemiology, diagnosis, and treatment. Clin Geriatr Med. 2014 Aug;30(3):421-42. doi: 10.1016/j.cger.2014.04.001. Epub 2014 Jun 12.
PubMed 25037289Langa KM, Levine DA. The diagnosis and management of mild cognitive impairment: a clinical review. JAMA. 2014 Dec 17;312(23):2551-61. doi: 10.1001/jama.2014.13806.
PubMed 25514304
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Preoperative Mild Cognitive Impairment on Postoperative Delirium in Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT07878676
- Acronym / sponsor ID
- The MCI study
- Conditions
- Neurocognitive Disorder, Cardiac Surgery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 261 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 16 Oct 2026 (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.
This study is intended to explore the impact of mild cognitive impairment on the incidence of delirium after cardiac surgery in older patients. The main question this study tries to answer is: Does preoperative mild cognitive impairment influence the incidence of postoperative delirium in cardiovascular surgery? Participants diagnosed with mild cognitive impairment who are supposed to perform cardiovascular surgery will answer questionnaires about cognitive function after surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MCI | – | –participants who are diagnosed with MCI before surgery |
| non-MCI | – | –participants with normal cognitive function before surgery |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Undergo elective cardiac surgery with cardiopulmonary bypass
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the 5-day incidence of postoperative delirium
Time frame: within five days postoperatively
the incedence of delirium evaluated by CAM/CAM-ICU
3 secondary outcomes
Time to extubation
Time frame: Perioperative
Length of stay (LOS) in intensive care unit (ICU)
Time frame: Perioperative
Length of stay (LOS) in hospital
Time frame: Perioperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Results publication: PubMed 29771710Brown CH 4th, Probert J, Healy R, Parish M, Nomura Y, Yamaguchi A, Tian J, Zehr K, Mandal K, Kamath V, Neufeld KJ, Hogue CW. Cognitive Decline after Delirium in Patients Undergoing Cardiac Surgery. Anesthesiology. 2018 Sep;129(3):406-416. doi: 10.1097/ALN.0000000000002253.
- Results publication: PubMed 41532517Srivatsa S, Sujanthan S, Paleczny S, Ripsman DA, de Rivera SN, Dimagli A, Taghdiri F, Cheng PS, Lou W, Farkouh ME, Fremes SE, Gaudino MF, Rabin J, Razzouk L, Owen AM, Creber RM, Swartz RH. Cognitive Outcomes in Randomized Controlled Trials of Coronary Artery Bypass Graft Surgery From 2005 to 2025: A Systematic Review. J Am Heart Assoc. 2026 Jan 20;15(2):e041946. doi: 10.1161/JAHA.125.041946. Epub 2026 Jan 14.
- Results publication: PubMed 30068225Jongsiriyanyong S, Limpawattana P. Mild Cognitive Impairment in Clinical Practice: A Review Article. Am J Alzheimers Dis Other Demen. 2018 Dec;33(8):500-507. doi: 10.1177/1533317518791401. Epub 2018 Aug 1.
- Results publication: PubMed 25037289Hugo J, Ganguli M. Dementia and cognitive impairment: epidemiology, diagnosis, and treatment. Clin Geriatr Med. 2014 Aug;30(3):421-42. doi: 10.1016/j.cger.2014.04.001. Epub 2014 Jun 12.
- Results publication: PubMed 25514304Langa KM, Levine DA. The diagnosis and management of mild cognitive impairment: a clinical review. JAMA. 2014 Dec 17;312(23):2551-61. doi: 10.1001/jama.2014.13806.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared in order to protect participant privacy and confidentiality.
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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.
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 Neurocognitive Disorder and Cardiac Surgery, run by Chinese Academy of Medical Sciences, Fuwai 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?
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: opening soon, as of the sponsor's last update on 16 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jia Shi, M.D. (+86 10 88322467, shijia@fuwai.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the 5-day incidence of postoperative delirium (time frame: within five days postoperatively). 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 NCT07878676, which also lists 5 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 16 Oct 2026.