MRI Maker of Perioperative Neurocognitive Disorder

Knee Osteoarthritis Clinical Trial

— MRIPND  

Official title:

MRI Marker of Postoperative Delirium and Delayed Neurocognitive Recovery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03773627
• Other study ID #: 2017-075
• Status: Recruiting
• Start date: December 12, 2018
• Est. completion date: July 30, 2020

Study information

• Verified date: December 2018
• Source: RenJi Hospital
• Contact: Diansan Su, Dr.
• Phone: +862168383702
• Email: diansansu[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 30, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fracture of Lower Limb
• Knee Osteoarthritis
• Necrosis
• Necrosis of Femoral Head
• Neurocognitive Disorders
• Osteoarthritis
• Osteoarthritis, Knee

Locations

Country	Name	City	State
China	Renji Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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