NCT02164669

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

June 12, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 16, 2014

Completed
Last Updated

June 16, 2014

Status Verified

May 1, 2013

Enrollment Period

1.1 years

First QC Date

June 12, 2014

Last Update Submit

June 13, 2014

Conditions

Postoperative Cognitive DysfunctionCognitive Impairment

Keywords

InflammationCoronary artery bypass graftMagnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

  • The brain structure changes

    Using BOLD fMRI to investigate the variance of mean diffusivity and FA in nerve conduction bundle

    7 days postoperatively

Secondary Outcomes (1)

  • Mini-Mental State Examination

    preoperative and 7 days, 3 months and 1 years postoperative

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijign Hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

4ml venous blood will be collected, and serum IL-6， IL-8，TNF-α，NSE，S100β will be detected.

MeSH Terms

Conditions

Postoperative Cognitive ComplicationsCognitive DysfunctionInflammation

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Qiang Wang, MD, PhD

    Xijing Hospital

    STUDY DIRECTOR

  • Zijun Gao, Dr.

    Xijing Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Qiang Wang, MD,PhD

CONTACT

+86-29-84775343Wangqiang@fmmu.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
7 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 12, 2014

First Posted

June 16, 2014

Study Start

May 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

June 16, 2014

Record last verified: 2013-05

Locations

CN(1)