Exploration of Neuroimaging and Biochemical Prognostic In... | NCT02164669

Studies
Exploration of Neuroimaging and Biochemical Prognostic Indicators for POCD

NCT02164669

Sponsor

wangqiang

Status

Unknown status

Last Update Posted

Jun 16, 2014Estimated

Enrollment

20Estimated

Phase

Not provided

Conditions

Postoperative Cognitive Dysfunction
Cognitive Impairment

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2013

Primary Completion Date

Jun 2014Estimated

Completion Date

Jun 2014Estimated

First Submitted Date

Jun 12, 2014

First Submission Date that Met QC Criteria

Jun 13, 2014

First Posted Date

Jun 16, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 13, 2014

Last Update Posted Date

Jun 16, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

7 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

20Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Qiang Wang, MD,PhD	Contact	+86-29-84775343		Wangqiang@fmmu.edu.cn

Overall Officials

Name	Affiliation	Role
Qiang Wang, MD, PhD	Xijing Hospital	Study Director
Zijun Gao, Dr.	Xijing Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Xijign Hospital	Recruiting	Xi'an	Shaanxi	710032	China

Condition Browse Module

MeSH Terms

ID	Term
D000079690	Postoperative Cognitive Complications
D060825	Cognitive Dysfunction
D007249	Inflammation

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D003072	Cognition Disorders

Browse Leaves

Not provided

Browse Branches

Not provided