NCT03773627

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 12, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

December 12, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2020

Completed
Last Updated

December 13, 2018

Status Verified

December 1, 2018

Enrollment Period

1 year

First QC Date

December 10, 2018

Last Update Submit

December 11, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • MRI markers of PND before 12 month after surgery

    From the 7th day after surgery to 12 month after surgery

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renji Hospital

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • qi lu, Dr.

    Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China

    STUDY DIRECTOR

Central Study Contacts

Diansan Su, Dr.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2018

First Posted

December 12, 2018

Study Start

December 12, 2018

Primary Completion

December 30, 2019

Study Completion

July 30, 2020

Last Updated

December 13, 2018

Record last verified: 2018-12

Locations