Exploration of Neuroimaging and Biochemical Prognostic Indicators for POCD

Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02164669
• Other study ID #: 20130225-8
• Status: Recruiting
• Phase: N/A
• First received: June 12, 2014
• Last updated: June 13, 2014
• Start date: May 2013
• Est. completion date: June 2014

Study information

• Verified date: May 2013
• Source: Xijing Hospital
• Contact: Qiang Wang, MD,PhD
• Phone: +86-29-84775343
• Email: Wangqiang[@]fmmu.edu.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Impairment
• Postoperative Cognitive Dysfunction

Locations

Country	Name	City	State
China	Xijign Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
wangqiang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The brain structure changes	Using BOLD fMRI to investigate the variance of mean diffusivity and FA in nerve conduction bundle	7 days postoperatively	No
Secondary	Mini-Mental State Examination	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	No