Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2026-03-12 @ 12:54 AM
Study NCT ID:
NCT05972057
Status:
UNKNOWN
Last Update Posted:
2023-09-08
First Post:
2023-04-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prediction Model of Long-term Cognitive Dysfunction and Delirium After Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003693', 'term': 'Delirium'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003072', 'term': 'Cognition Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006348', 'term': 'Cardiac Surgical Procedures'}], 'ancestors': [{'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2025-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-06', 'studyFirstSubmitDate': '2023-04-06', 'studyFirstSubmitQcDate': '2023-07-24', 'lastUpdatePostDateStruct': {'date': '2023-09-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative delirium', 'timeFrame': 'up to 5 days after surgery', 'description': 'To establish a risk factor prediction model for postoperative delirium in patients aged 65 and over undergoing elective cardiac surgery by detecting peripheral blood biomarkers by CyTOF.'}], 'secondaryOutcomes': [{'measure': 'long-term cognitive dysfunction', 'timeFrame': '1 year after surgery', 'description': 'To establish a risk factor prediction model for long-term cognitive impairment in patients aged 65 and over undergoing elective cardiac surgery by detecting peripheral blood biomarkers by CyTOF.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Delirium', 'Cognitive Dysfunction']}, 'descriptionModule': {'briefSummary': "Delirium is a clinical syndrome caused by normal dysfunction of the brain, characterized by reduced awareness and responsiveness to the environment, as well as orientation disorders, incoherent thinking and memory disorders. Delirium indicates poor recovery of cognitive function, decreased ability of daily life, may need to enter nursing homes, and even lead to adverse outcomes such as death. According to a number of clinical studies, middle-aged and elderly people are prone to delirium after undergoing major surgery. Delirium occurs in 31 % -40 % of patients over 50 years old after cardiac surgery. Compared with patients without postoperative delirium, patients with postoperative delirium had significant cognitive impairment within 1 year after cardiac surgery. The occurrence of delirium suggests that the patient 's brain has become fragile, cognitive function has begun to decline, and the risk of future dementia has increased.\n\nSecondly, delirium and dementia have overlapping clinical features and common pathogenic mechanisms. Some scholars even speculate that delirium and dementia represent different stages of a common process. It is generally believed that the peripheral immune system may be involved in the pathogenesis and progression of dementia through the dysfunctional blood-brain barrier. The activation of microglia and astrocytes leads to the release of chemokines, which can recruit peripheral immune cells to the central nervous system. At the same time, cytokines released by peripheral cells can cross the blood-brain barrier and act on glial cells to change their phenotype.\n\nThis study is a prospective cohort study of patients aged 65 and over who are about to undergo elective cardiac surgery.CyTOF can achieve accurate immunophenotyping of cell populations while comprehensively and accurately detecting and analyzing cytokines and signaling pathways. Therefore, the detection of peripheral blood biomarkers may effectively predict the risk of long-term cognitive dysfunction and postoperative delirium in patients undergoing cardiac surgery."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'During the implementation of the project, all patients with cardiac surgery who met the inclusion criteria were included in the Department of Cardiac Surgery of Renji Hospital. The total sample size was the sum of all patients by the project deadline.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 65 years\n* Patients undergoing elective cardiac surgery with cardiopulmonary bypass\n* Sign informed consent\n\nExclusion Criteria:\n\n* serious dementia, encephalopathy, mental illness or other neurological diseases\n* Patients who could not take neurocognitive tests due to other reasons ( such as language, hearing or visual impairment )\n* Patients with stage 3 or 4 malignant tumors, and patients with pancreatic cancer, gallbladder cancer, cholangiocarcinoma and other tumors with high malignancy and expected survival time less than 1 year\n* American Society of Anesthesiologists ( ASA ) classification IV or V patients'}, 'identificationModule': {'nctId': 'NCT05972057', 'briefTitle': 'Prediction Model of Long-term Cognitive Dysfunction and Delirium After Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'A Prediction Model of Long-term Postoperative Cognitive Dysfunction and Delirium After Cardiac Surgery Based on Peripheral Blood Biomarkers： A Prospective Cohort Study(PPSB)', 'orgStudyIdInfo': {'id': 'PPSB'}}, 'armsInterventionsModule': {'interventions': [{'name': 'cardiac surgery', 'type': 'PROCEDURE', 'description': 'All cardiac surgery patients who met the inclusion criteria were included in the cardiac surgery department of Renji Hospital.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '200127', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'DAN HUANG, MS', 'role': 'CONTACT', 'email': 'huangdan@renji.com', 'phone': '+8615921108822'}, {'name': 'XIA JIN, PD', 'role': 'CONTACT', 'email': 'jinxia026779@renji.com', 'phone': '+8618094575236'}, {'name': 'DAN HUANG, MS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Renji Hospital, Shanghai Jiao Tong University, School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Li Peiying, Ph.D.', 'role': 'CONTACT', 'email': 'peiyingli.md@gmail.com', 'phone': '+8615800616866'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RenJi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}