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Correlation Between Postoperative Cognitive Dysfunction and Telomere Length in Patients With Non-cardiac Surgery

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: NCT03703973
Recruitment Status : Recruiting
First Posted : October 12, 2018
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
Han Yuan, Xuzhou Medical University

Brief Summary:
To study on the Postoperative Cognitive Dysfunction: Correlations With Leukocyte telomere length。

Condition or disease Intervention/treatment
Postoperative Cognitive Dysfunction Diagnostic Test: Neuropsychology test

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Correlation Between Postoperative Cognitive Dysfunction and Telomere Length in Patients With Non-cardiac Surgery
Actual Study Start Date : August 1, 2016
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Group/Cohort Intervention/treatment
study group
1000 Male and female patients undergoing non-cardiac surgery at the Affiliated Hospital of Xuzhou Medical University [Jiangsu China]. We do the neuropsychological tests, Mini-Mental score examination (MMSE) and olfaction test 1 day before (baseline) and 1 week,3 months,1 year and 3 years after surgery without safety issue.We also measure their preoperative leukocyte telomere length.
Diagnostic Test: Neuropsychology test
We do the neuropsychological tests, Mini-Mental score examination (MMSE) and olfaction test 1 day before (baseline) and 1 week,3 months,1 year and 3 years after surgery without safety issue.

control group
We enroll 50 healthy volunteers and do the neuropsychological tests, Mini-Mental score examination (MMSE) and olfaction test at 1 day (baseline), 1 week, 3 months, 1 year and 3 years without safety issue.
Diagnostic Test: Neuropsychology test
We do the neuropsychological tests, Mini-Mental score examination (MMSE) and olfaction test 1 day before (baseline) and 1 week,3 months,1 year and 3 years after surgery without safety issue.




Primary Outcome Measures :
  1. the neuropsychological test to measure cognitive function [ Time Frame: 1 day before surgery(baseline) ]
  2. Mini-Mental score examination [MMSE] used for screening of dementia [ Time Frame: 1 day before surgery(baseline) ]
  3. the leukocyte telomere length [ Time Frame: on the surgery day ]
  4. the neuropsychological test to measure cognitive function [ Time Frame: within the first 7 days (plus or minus 2 days) after surgery ]
  5. Mini-Mental score examination [MMSE] used for screening of dementia [ Time Frame: within the first 7 days (plus or minus 2 days) after surgery ]
  6. the neuropsychological test to measure cognitive function [ Time Frame: within the first 3 months (plus or minus 1 month) after surgery ]
  7. Mini-Mental score examination [MMSE] used for screening of dementia [ Time Frame: within the first 3 months (plus or minus 1 month) after surgery ]
  8. the neuropsychological test to measure cognitive function [ Time Frame: within the first 1 year (plus or minus 3 months) after surgery ]
  9. Mini-Mental score examination [MMSE] used for screening of dementia [ Time Frame: within the first 1 year (plus or minus 3 months) after surgery ]
  10. the neuropsychological test to measure cognitive function [ Time Frame: within the first 3 years (plus or minus 1 year) after surgery ]
  11. Mini-Mental score examination [MMSE] used for screening of dementia [ Time Frame: within the first 3 years (plus or minus 1 year) after surgery ]


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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
We included 1000 Male and female patients undergoing non-cardiac surgery and 50 healthy volunteers at the affiliated hospital of Xuzhou Medical University.
Criteria

Inclusion Criteria:

  • Non-cardiac surgery patients;

    • Age is greater than or equal to 65 years old;

      • Han Nationality, mother tongue is chinese;

        ④The MMSE score:Illiteracy is greater than or equal to 17 points, primary school is greater than or equal to 20 points, higher secondary school is more than 24 points;

        ⑤The Geriatric Depression Scale (GDS) grade 1 or 2;

        ⑥The important function without serious heart, brain, liver, kidney, lung and other organs;

        • The ASA class I or II;

          • The people signed informed consent.

Exclusion Criteria:

  • The diagnosis of neurological and psychiatric disorders, such as Alzheimer's disease, Parkinson's syndrome, multiple sclerosis, schizophrenia, depression, etc.; ②Had severe head and face disease, trauma history or history of surgery;

    • Had a history of influenza in 3 weeks; ④The serious body disease and tobacco, wine and other substance abuse history; ⑤The presence of malignant tumor with shorter survival disease.

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): NCT03703973


Contacts
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Contact: Junli Cao +86 15162160809 caojl0310@yahoo.com.cn
Contact: Yuan Han +86 13852470693 hanyuan_trial@163.com

Locations
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China, Jiangsu
Department of Anesthesia of the Affiliated Hospital of Xuzhou Medical University Recruiting
Xuzhou, Jiangsu, China
Contact: Junli Cao    +86 15162160809    caojl0310@yahoo.com.cn   
Contact: Yuan Han    +86 13852470693    hanyuan_trial@163.com   
Sponsors and Collaborators
Xuzhou Medical University
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Responsible Party: Han Yuan, Doctor-in-charge of Anesthetist, Xuzhou Medical University
ClinicalTrials.gov Identifier: NCT03703973    
Other Study ID Numbers: POCDLTL
First Posted: October 12, 2018    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Keywords provided by Han Yuan, Xuzhou Medical University:
Postoperative Cognitive Dysfunction
Leukocyte Telomere Length
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders