MRI Maker of Perioperative Neurocognitive Disorder | NCT03773627

Studies
MRI Maker of Perioperative Neurocognitive Disorder

NCT03773627

Sponsor

RenJi Hospital

Status

Unknown status

Last Update Posted

Dec 13, 2018Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Necrosis of Femoral Head
Knee Osteoarthritis
Fracture of Lower Limb

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 12, 2018Actual

Primary Completion Date

Dec 30, 2019Estimated

Completion Date

Jul 30, 2020Estimated

First Submitted Date

Dec 10, 2018

First Submission Date that Met QC Criteria

Dec 10, 2018

First Posted Date

Dec 12, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 11, 2018

Last Update Posted Date

Dec 13, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Diansan Su, Dr.	Contact	+862168383702		diansansu@yahoo.com

Overall Officials

Name	Affiliation	Role
qi lu, Dr.	Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Renji Hospital	Recruiting	Shanghai	Shanghai Municipality	200127	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020370	Osteoarthritis, Knee

Ancestor Terms

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided