Detection of Microplastics in Cardiac Surgery Patients | NCT05600010

Studies
Detection of Microplastics in Cardiac Surgery Patients

NCT05600010

Sponsor

Kun Hua

Status

Unknown status

Last Update Posted

Nov 2, 2022Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

Cardiac Surgery
Microplastics
Nanoplastics
Cardiovascular Diseases

Interventions

Microplastics

Countries

Not provided

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

Oct 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2022Estimated

Primary Completion Date

May 31, 2023Estimated

Completion Date

Oct 22, 2023Estimated

First Submitted Date

Oct 26, 2022

First Submission Date that Met QC Criteria

Oct 26, 2022

First Posted Date

Oct 31, 2022Actual

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

Oct 31, 2022

Last Update Posted Date

Nov 2, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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 exponential growth in plastic production/use translates into a parallel increase in environmental plastic waste, which is constantly degraded into microplastics and nanoplastics. Information on the effects of microplastics on human health is still preliminary.

Cardiac surgery patients is a population high exposed to plastics. This observational study will obtain biological samples of cardiac surgery patients as a reference and vulnerable group of individuals highly exposed to microplastics and potentially more susceptible.

The objective of this research is to be able to detect microplastics on blood and operation samples of cardiac surgery patients as well as their potential genotoxic and immunological damage.

Detailed Description

Not provided

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

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study group		Detection of microplastics/nanoplastics in heart tissue and the blood of patients undergoing cardiac surgery	Other: Microplastics

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Microplastics	Other	Detection of microplastics as a yes/no value	Study group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Detection of microplastics in human heart tissue and the blood	Detection of microplastics in human heart tissue and the blood undergoing cardiac surgery	perioperative: preoperative and pro-/postoperative blood and intraoperative heart tissue

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥18 years
Elective cardiac surgery

Exclusion Criteria:

Emergency surgery or limited-term surgery
Previous cardiac surgery
Previous severe liver disease
Pregnant or planning to become pregnant
Have a malignant tumor

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

Cardiac surgery patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kun Hua, M.D.	Contact	+8615810111206		huakun0310@126.com

Overall Officials

Name	Affiliation	Role
Kun Hua	Beijing Anzhen Hospital	Study Chair

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002318	Cardiovascular Diseases

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000080545	Microplastics

Ancestor Terms

ID	Term
D010969	Plastics
D011108	Polymers
D046911	Macromolecular Substances
D001697	Biomedical and Dental Materials

Browse Leaves

Not provided

Browse Branches

Not provided