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MRI Maker of Perioperative Neurocognitive Disorder (MRIPND)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03773627
Recruitment Status : Recruiting
First Posted : December 12, 2018
Last Update Posted : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
RenJi Hospital

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.

Condition or disease
Necrosis of Femoral Head Knee Osteoarthritis Fracture of Lower Limb

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: MRI Marker of Postoperative Delirium and Delayed Neurocognitive Recovery
Actual Study Start Date : December 12, 2018
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : July 30, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. MRI markers of PND before 7th day after surgery [ Time Frame: From the day before surgery to the 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


Secondary Outcome Measures :
  1. MRI markers of PND before 12 month after surgery [ Time Frame: From the 7th day after surgery to 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



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03773627


Contacts
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Contact: Diansan Su, Dr. +862168383702 diansansu@yahoo.com

Locations
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China, Shanghai
Renji Hospital Recruiting
Shanghai, Shanghai, China, 200127
Contact: Diansan Su    +862168383702    diansansu@yahoo.com   
Principal Investigator: Linke Chen         
Sponsors and Collaborators
RenJi Hospital
Investigators
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Study Director: qi lu, Dr. Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China
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Responsible Party: RenJi Hospital
ClinicalTrials.gov Identifier: NCT03773627    
Other Study ID Numbers: 2017-075
First Posted: December 12, 2018    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Necrosis
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pathologic Processes