Exploration of Neuroimaging and Biochemical Prognostic Indicators for POCD

June 13, 2014 updated by: wangqiang

Exploration of Neuroimaging and Biochemical Prognostic Indicators for Post-operative Cognitive Dysfunction After Coronary Artery Bypass Graft

Postoperative cognitive dysfunction (POCD) may lead to serious consequences. But the underlying mechanisms are still unclear. Blood Oxygen Level Dependent (BOLD) fMRI and biochemical indicators will be used to explore the underlying mechanisms and represent a promising precursory target for diagnosis and treatment of POCD.

Study Overview

Status

Unknown

Conditions

Detailed Description

Postoperative cognitive dysfunction (POCD) is one of the most common complications in patients undergoing cardiac surgery. POCD will not only increase the incidence of complications and mortality, but also influence the quality of life after discharging from the hospital. Many factors are associated with POCD, such as neuroinflammation, age, anesthetics, surgery stress response and genetic factors. But the underlying mechanisms are still unclear. Blood Oxygen Level Dependent (BOLD) fMRI, which could monitor the peripheral neuron spontaneous activity according to the ratio of oxyhemoglobin and deaeration hemoglobin in blood, will be used to investigate whether POCD is induced by the variance in neurons metabolism and spontaneous activity in brain regions. Meanwhile, biochemical indicators will be detected to explore the prompting indicators of POCD. The present study is aimed to represent a promising precursory target for diagnosis and treatment of POCD, and provide novel evidence and insights on the brain changes induced by POCD.

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Recruiting
        • Xijign Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients will selective undergo Coronary Artery Bypass Grafting (CABG) surgery. Health adult

Description

Inclusion Criteria:

  • Aged 18-80 years old
  • Underwent selective CABG surgery

Exclusion Criteria:

  • History of central nervous system or psychiatric disorders
  • History of taking sedative, antidepressants, or alcoholism
  • MMSE score less than 23
  • Visual or auditory disorders
  • Educated less than 7 years
  • Claustrophobia
  • Can not be supine
  • Can not tolerate iodinated contrast agents

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The brain structure changes
Time Frame: 7 days postoperatively
Using BOLD fMRI to investigate the variance of mean diffusivity and FA in nerve conduction bundle
7 days postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mini-Mental State Examination
Time Frame: preoperative and 7 days, 3 months and 1 years postoperative
Application of digital depth and breadth to test digital sign test Tracking the attachment test and assess depression self rating scale
preoperative and 7 days, 3 months and 1 years postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

wangqiang

Investigators

  • Study Director: Qiang Wang, MD, PhD, Xijing Hospital
  • Principal Investigator: Zijun Gao, Dr., Xijing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Anticipated)

June 1, 2014

Study Completion (Anticipated)

June 1, 2014

Study Registration Dates

First Submitted

June 12, 2014

First Submitted That Met QC Criteria

June 13, 2014

First Posted (Estimate)

June 16, 2014

Study Record Updates

Last Update Posted (Estimate)

June 16, 2014

Last Update Submitted That Met QC Criteria

June 13, 2014

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20130225-8

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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