NCT05600010

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2022

Shorter than P25 for all trials

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 31, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 22, 2023

Completed
Last Updated

November 2, 2022

Status Verified

October 1, 2022

Enrollment Period

7 months

First QC Date

October 26, 2022

Last Update Submit

October 31, 2022

Conditions

Cardiac SurgeryMicroplasticsNanoplasticsCardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Study group

Detection of microplastics/nanoplastics in heart tissue and the blood of patients undergoing cardiac surgery

Other: Microplastics

Interventions

MicroplasticsOTHER

Detection of microplastics as a yes/no value

Study group

Eligibility Criteria

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

Cardiac surgery patients

You may qualify if:

  • Age ≥18 years
  • Elective cardiac surgery

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Blood; cardiac tissue

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Microplastics

Intervention Hierarchy (Ancestors)

PlasticsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Kun Hua

    Beijing Anzhen Hospital

    STUDY CHAIR

Central Study Contacts

Kun Hua, M.D.

CONTACT

+8615810111206huakun0310@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Deputy Chief Surgeon

Study Record Dates

First Submitted

October 26, 2022

First Posted

October 31, 2022

Study Start

November 1, 2022

Primary Completion

May 31, 2023

Study Completion

October 22, 2023

Last Updated

November 2, 2022

Record last verified: 2022-10