Cardiac SurgeryNCT05600010
Detection of Microplastics in Cardiac Surgery Patients
An observational study of Cardiac Surgery and Microplastics, run by Kun Hua.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiac Surgery, Microplastics, Nanoplastics
- What is being tested?
- Microplastics
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2022to 22 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cardiac surgery patients
Who may be able to join
- Age ≥18 years
- Elective cardiac surgery
Who cannot join
- Emergency surgery or limited-term surgery
- Previous cardiac surgery
- Previous severe liver disease
- Pregnant or planning to become pregnant
- Have a malignant tumor
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Detection of Microplastics in Cardiac Surgery Patients: Its Metabolic Pathways and Toxic Effects
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.
- Conditions
- Cardiac Surgery, Microplastics, Nanoplastics, Cardiovascular Diseases
- Being tested
- Microplastics
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicroplasticsOther
Detection of microplastics as a yes/no value
| Study group | Role | What they receive |
|---|---|---|
| Study group | Detection of microplastics/nanoplastics in heart tissue and the blood of patients undergoing cardiac surgery Receives: Other: Microplastics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of microplastics in human heart tissue and the blood
Detection of microplastics in human heart tissue and the blood undergoing cardiac surgery
Measured: perioperative: preoperative and pro-/postoperative blood and intraoperative heart tissue
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start1 Nov 2022 (estimated)
- Primary completion31 May 2023 (estimated)
- Study completion22 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kun Hua
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kun Hua, Beijing Anzhen Hospital
- Investigators
- Kun Hua, Study chair, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05600010
- Sponsor's protocol ID
- default
- Status last verified
- Oct 2022
- First submitted
- 26 Oct 2022
- Last updated
- 2 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Microplastics in Cardiac Surgery Patients: Its Metabolic Pathways and Toxic Effects
- ClinicalTrials.gov ID
- NCT05600010
- Acronym / sponsor ID
- default
- Conditions
- Cardiac Surgery, Microplastics, Nanoplastics, Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kun HuaUniversity, hospital or other
- Study start
- 1 Nov 2022 (estimated)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 22 Oct 2023 (estimated)
- First posted
- 31 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Other: MicroplasticsDetection of microplastics/nanoplastics in heart tissue and the blood of patients undergoing cardiac surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cardiac surgery patients
Key inclusion criteria (2 listed)
- Age ≥18 years
- Elective cardiac surgery
Key exclusion criteria (5 listed)
- Emergency surgery or limited-term surgery
- Previous cardiac surgery
- Previous severe liver disease
- Pregnant or planning to become pregnant
- Have a malignant tumor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MicroplasticsDetection of microplastics as a yes/no value | Other | Study group |
Primary outcome
Detection of microplastics in human heart tissue and the blood
Time frame: perioperative: preoperative and pro-/postoperative blood and intraoperative heart tissue
Detection of microplastics in human heart tissue and the blood undergoing cardiac surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kun Hua study chair
Beijing Anzhen Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Surgery and Microplastics, run by Kun Hua.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kun Hua, M.D. (+8615810111206, huakun0310@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of microplastics in human heart tissue and the blood (time frame: perioperative: preoperative and pro-/postoperative blood and intraoperative heart tissue). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022.