MRI Maker of Perioperative Neurocognitive Disorder (MRIPND)

MRI Marker of Postoperative Delirium and Delayed Neurocognitive Recovery

Periperative neurocognitive disorder(PND) is consistently associated with increased morbidity and mortality, but its mechanisms remain unclear. Moreover, valid biomarkers for the prediction or diagnosis of the development of delayed neurocognitive recovery in aged patients have not been identified so far. The purpose of this study is trying to find the functional MRI marker of PND.

Study Overview

• Status: Unknown
• Conditions: Knee Osteoarthritis; Necrosis of Femoral Head; Fracture of Lower Limb

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • Recruiting
      • RenJi Hospital
      • Principal Investigator: Linke Chen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients elder than 60 years old elective to undergo lower limb surgery and conform to the including criteria would be recruited.

Description

Inclusion Criteria:

• Age ≥ 60 years
• Spoke proficient Chinese
• Selected to lower limb osteopathic surgery
• Informed consent signed by the patient
• Underwent general anesthesia

Exclusion Criteria:

• Existing cerebral disease, or have a history of neurological and psychiatric diseases including AD, stroke, and psychosis
• Existing cognitive impairment as evidenced by Mini-Mental State Examination scores below 24
• Several audition or vision disorder
• With standard contraindications to MRI examinations
• Unwillingness to comply with the protocol or procedures.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MRI markers of PND before 7th day after surgery	To analysis the association of volume of hippocampus measured by MRI and the occurrence of PND identified at the 7th day after surgery	From the day before surgery to the 7th day after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MRI markers of PND before 12 month after surgery	To analysis the association of volume of hippocampus measured by MRI and the occurrence of PND identified at the 12 months after surgery	From the 7th day after surgery to 12 month after surgery

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Investigators: Study Director: qi lu, Dr., Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2018
• Primary Completion (Anticipated): December 30, 2019
• Study Completion (Anticipated): July 30, 2020

Study Registration Dates

• First Submitted: December 10, 2018
• First Submitted That Met QC Criteria: December 10, 2018
• First Posted (Actual): December 12, 2018

Study Record Updates

• Last Update Posted (Actual): December 13, 2018
• Last Update Submitted That Met QC Criteria: December 11, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Necrosis
• Other Study ID Numbers: 2017-075

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No