Key circRNA Identification of Postoperative Delirium in E... | NCT05743660

Studies
Key circRNA Identification of Postoperative Delirium in Elderly Patients Undergoing Cardiac Surgery

NCT05743660

Sponsor

Xuzhou Central Hospital

Status

Unknown status

Last Update Posted

Mar 7, 2023Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Postoperative Delirium

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

Feb 2023

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

Jun 30, 2022Actual

Primary Completion Date

May 30, 2023Estimated

Completion Date

Sep 30, 2023Estimated

First Submitted Date

Feb 14, 2023

First Submission Date that Met QC Criteria

Feb 14, 2023

First Posted Date

Feb 24, 2023Actual

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

Mar 4, 2023

Last Update Posted Date

Mar 7, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

The observational study aims to discover differentially expressed circRNAs in the peripheral blood of patients with postoperative delirium, which aims to answer the main questions at:

Whether there are changes in circRNA expression in peripheral blood in elderly patients with delirium after cardiopulmonary bypass surgery? Whether the circRNA with altered expression plays an important role in the occurrence and development of POD? What are the functions and underlying mechanisms of circRNA with altered expression in POD? Voluntary patients will receive follow-up 1 day before and 7 days after surgery to assess their cognitive function, and peripheral blood will be collected 1 day before and 3 days after surgery. The study divided patients into POD group and non-POD group according to whether delirium occurred within 7 days after surgery.

Detailed Description

Investigators combined qRT-PCR by performing circRNAs chip analysis to study differential expression of circRNAs in plasma samples of elderly patients with non-POD who underwent cardiac surgery under general anesthesia and cardiopulmonary bypass. Subsequently, miRNA binding sites and associated mRNAs are predicted by bioinformatics analysis. Moreover, we plan to construct predicted circN-MIRNA-MRNA co-expression networks to study the main functions and pathways of target genes, thereby attempting to provide a preliminary view of the potential role of a circRNA in POD. The study may provide an important perspective on the differential expression of circRNA in patients with POD, and may also provide insights into biomarkers and therapeutic targets of POD.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
POD group		According to the occurrence of postoperative delirium, the patients were divided into POD group and non-POD group
non-POD group		According to the occurrence of postoperative delirium, the patients were divided into POD group and non-POD group

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Differences in circRNA microarrays before and after surgery	Plasma was isolated from peripheral blood, RNA samples were prepared, and circRNA microarray analysis was performed. The differences in circRNA expression in peripheral blood of POD patients and non-POD patients were comprehensively analyzed.	1 day before surgery，3 day after surgery
3-minute Diagnostic Interview for CAM	Postoperative delirium was assessed by 3-minute Diagnostic Interview for confusion assessment method (CAM).	Consecutive 7 days after the surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Be over 50 years old;
ASA Grade I-III;
Heart surgery is planned under general anesthesia.

Exclusion Criteria:

Patients with the second surgery;
The ejection fraction is less than 40%;
The score of the preoperative simple mental status examination (MMSE) is less than 24 points;
Patients with mental illness or central nervous system disease;
Patients who cannot or refuse to complete MMSE before surgery.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing heart surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yangzi Zhu, Doctor	Contact	+86 18168779150		zhuyz@188.com
Liwei Wang, Doctor	Contact	+86 18952170255		doctorlww@sina.com

Overall Officials

Name	Affiliation	Role
Yangzi Zhu, Doctor	Xuzhou Central Hospital	Principal Investigator
Liwei Wang, Doctor	Xuzhou Central Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Xuzhou Central Hospital	Recruiting	Xuzhou	Jiangsu	221000	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000071257	Emergence Delirium

Ancestor Terms

ID	Term
D003693	Delirium
D003221	Confusion
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations

Browse Leaves

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Browse Branches

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