Microplastics and Nanoplastics in Patients With Chronic Coronary Syndromes (CCS-Plastics)

June 6, 2026 updated by: Emanuele Barbato, Azienda Ospedaliera "Sant'Andrea"
The CCS-plastics is an investigator-initiated, prospective, multicenter study of patients undergoing coronary CT angiography (CCTA) for suspected or known chronic coronary syndromes (CCS) referred to invasive coronary angiography for clinical indication. Patients identified as eligible for the protocol will be asked for written consent to participate in the study. The patients' dossiers will be uploaded and transmitted to the core laboratory for analysis. The routine management of the CCS patients will not be affected and all patients will be managed according to current standards. Invasive coronary angiography and coronary blood samples will be performed following the current standards, guidelines, and indications. During invasive coronary angiography, coronary blood samples will be collected per standard of care and sent to a centralized, specialized core laboratory for MNPs and biomarkers analysis. The central core lab for MNPs analyses will be the University of Campania Luigi Vanvitelli, Naples, Italy. The identification, quantification (concentration, mcg/ml), and typing of plastic particles will be performed in each tube for each patient, using pyrolysis-gas chromatography-mass spectrometry (Py-GC/MS) and laser direct infrared (LDIR) spectroscopy. The CCTA will be centrally analyzed by Centro Cardiologico Monzino to evaluate qualitative and quantitative plaque features. Patients will be followed clinically at 1 and 3 years per standard of care.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Clinical Research Unit Cardiology Dept. Sant'Andrea University Hospital
  • Phone Number: +39 0633778763
  • Email: cru.cardiologia@uniroma1.it

Study Contact Backup

Study Locations

  • Italy
      • Caserta, Italy
        • Not yet recruiting
        • Division of Cardiology, A.O.R.N. "Sant'Anna e San Sebastiano", Caserta, Italy.
        • Sub-Investigator:
          • Felice Gragnano, MD, PhD
        • Contact:
      • Forlì, Italy
        • Not yet recruiting
        • Cardiovascular Division, Morgagni-Pierantoni University Hospital, Forlì, Italy.
        • Contact:
        • Sub-Investigator:
          • Luca Bergamaschi, MD, PhD
        • Sub-Investigator:
          • Matteo Armillotta, MD
        • Sub-Investigator:
          • Francesco Angeli, MD
      • Milan, Italy
        • Active, not recruiting
        • Centro Cardiologico Monzino
      • Naples, Italy
        • Active, not recruiting
        • Department of Advanced Medical and Surgical Sciences, University of Campania-Luigi Vanvitelli, Naples, Italy.
      • Roma, Italy
        • Recruiting
        • Sant'Andrea University Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Pasquale Paolisso, MD, PhD
        • Sub-Investigator:
          • Marta Belmonte, MD, PhD
        • Sub-Investigator:
          • Emanuele Gallinoro, MD, PhD
        • Sub-Investigator:
          • Matteo Casenghi, MD, PhD
      • Verona, Italy
        • Recruiting
        • Azienda Ospedaliera Integrata Verona, Italy
        • Contact:
        • Sub-Investigator:
          • Roberto Scarsini, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Consecutive patients undergoing coronary CT angiography (CCTA) for suspected or known chronic coronary syndromes (CCS) referred to invasive coronary angiography for clinical indication.

Description

Inclusion Criteria:

ALL the following:

  1. Age > 18 years old;
  2. Suspected or known chronic coronary syndromes undergoing coronary CT angiography;
  3. Clinical indication to invasive coronary angiography;
  4. Able to give informed consent.

Exclusion Criteria:

  1. Coronary CT angiography not available;
  2. Poor quality CCTA;
  3. Absence of native coronary stenosis >=50% at CCTA;
  4. Contraindications to invasive coronary angiography and percutaneous coronary intervention
  5. Life expectancy < 1 year due to non-cardiac pathology

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
CCS patients with presence of micro- and nano-plastics (MNPs+)
Consecutive patients undergoing coronary CT angiography (CCTA) for suspected or known chronic coronary syndromes (CCS) referred to invasive coronary angiography for clinical indication with the presence of micro- and nano-plastics (MNPs +).
CCS patients without the presence of micro- and nano-plastics (MNPs-)
Consecutive patients undergoing coronary CT angiography (CCTA) for suspected or known chronic coronary syndromes (CCS) referred to invasive coronary angiography for clinical indication without the presence of micro- and nano-plastics (MNPs -).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Burden of micro- and nanoplastics (MNPs) in the coronary blood of patients with chronic coronary syndromes (CCS) and obstructive coronary artery disease (CAD)
Time Frame: From enrollment until the date of hospital discharge, assessed up to 7 days
To measure the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in the coronary blood of patients with chronic coronary syndromes (CCS) and obstructive CAD (diameter stenosis>50%)
From enrollment until the date of hospital discharge, assessed up to 7 days
Burden of micro- and nanoplastics (MNPs) in the coronary blood of patients with chronic coronary syndromes (CCS) and plaque features at coronary computed tomography angiography.
Time Frame: From enrollment until the date of hospital discharge, assessed up to 7 days
Correlation of the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in the coronary blood of patients with chronic coronary syndromes (CCS) with quantitative and qualitative plaque features at coronary computed tomography angiography.
From enrollment until the date of hospital discharge, assessed up to 7 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Correlation of the burden of micro- and nanoplastics (MNPs) in the coronary blood of patients with chronic coronary syndromes (CCS) with diameter stenosis at coronary computed tomography angiography (CCTA).
Time Frame: From enrollment until the date of hospital discharge, assessed up to 7 days.
To correlate the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in the coronary blood of patients with chronic coronary syndromes (CCS) with the diameter stenosis at coronary computed tomography angiography (CCTA).
From enrollment until the date of hospital discharge, assessed up to 7 days.
Correlation of the burden of micro- and nanoplastics (MNPs) in the coronary blood of patients with chronic coronary syndromes (CCS) with plaque burden at coronary computed tomography angiography (CCTA).
Time Frame: From enrollment until the date of hospital discharge, assessed up to 7 days
To correlate the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in the coronary blood of patients with chronic coronary syndromes (CCS) with plaque burden at coronary computed tomography angiography (CCTA).
From enrollment until the date of hospital discharge, assessed up to 7 days
Correlation of the burden of micro- and nanoplastics (MNPs) in the coronary blood of patients with chronic coronary syndromes (CCS) with plaque morphology at coronary computed tomography angiography (CCTA).
Time Frame: From enrollment until the date of hospital discharge, assessed up to 7 days
To correlate the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in the coronary blood of patients with chronic coronary syndromes (CCS) with plaque morphology at coronary computed tomography angiography (CCTA).
From enrollment until the date of hospital discharge, assessed up to 7 days
Correlation of the burden of micro- and nanoplastics (MNPs) in the coronary blood of patients with chronic coronary syndromes (CCS) with the presence of high-risk plaque features at coronary computed tomography angiography (CCTA).
Time Frame: From enrollment until the date of hospital discharge, assessed up to 7 days
To correlate the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in the coronary blood of patients with chronic coronary syndromes (CCS) with the presence of high-risk plaque features at coronary computed tomography angiography (CCTA).
From enrollment until the date of hospital discharge, assessed up to 7 days
Correlation of the burden of micro- and nanoplastics (MNPs) in the coronary blood of patients with chronic coronary syndromes (CCS) with the presence and burden of calcium at coronary computed tomography angiography (CCTA).
Time Frame: From enrollment until the date of hospital discharge, assessed up to 7 days.
To correlate the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in the coronary blood of patients with chronic coronary syndromes (CCS) with the presence and burden of calcium at coronary computed tomography angiography (CCTA).
From enrollment until the date of hospital discharge, assessed up to 7 days.
Correlation of the burden of micro- and nanoplastics (MNPs) in the coronary blood of patients with chronic coronary syndromes (CCS) with the pericoronary fat attenuation index at coronary computed tomography angiography (CCTA).
Time Frame: From enrollment until the date of hospital discharge, assessed up to 7 days
To correlate the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in the coronary blood of patients with chronic coronary syndromes (CCS) with the pericoronary fat attenuation index at coronary computed tomography angiography (CCTA).
From enrollment until the date of hospital discharge, assessed up to 7 days
Correlation of the burden of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with vessel-specific ischemia.
Time Frame: From enrollment until the date of hospital discharge, assessed up to 7 days
To correlate the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with vessel-specific ischemia.
From enrollment until the date of hospital discharge, assessed up to 7 days
Correlation of the burden of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with platelet reactivity
Time Frame: From enrollment until the date of hospital discharge, assessed up to 7 days
To correlate the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with platelet reactivity as assessed by aggregometry.
From enrollment until the date of hospital discharge, assessed up to 7 days
Correlation of the burden of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with the occurrence of periprocedural events.
Time Frame: From enrollment until the date of hospital discharge, assessed up to 7 days
To correlate the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with the occurrence of periprocedural events.
From enrollment until the date of hospital discharge, assessed up to 7 days
Correlation of the burden of micro- and nanoplastics (MNPs) with major adverse cardiovascular events (cardiovascular death, myocardial infarction, any revascularization, hospitalization for heart failure) at 1-year follow-up.
Time Frame: From enrollment to 1-year follow-up.
To correlate the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with major adverse cardiovascular events (cardiovascular death, myocardial infarction, any revascularization, hospitalization for heart failure) at 1-year follow-up.
From enrollment to 1-year follow-up.
Correlation of the burden of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with all-cause death at 1-year follow-up.
Time Frame: From enrollment to 1-year follow-up.
To correlate the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with all-cause death at 1-year follow-up.
From enrollment to 1-year follow-up.
Correlation of the burden of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with cardiovascular death at 1-year follow-up.
Time Frame: From enrollment to 1-year follow-up.
To correlate the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with cardiovascular death at 1-year follow-up.
From enrollment to 1-year follow-up.
The correlation of the burden of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with myocardial infarction at 1-year follow-up.
Time Frame: From enrollment to 1-year follow-up.
To correlate the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with myocardial infarction at 1-year follow-up.
From enrollment to 1-year follow-up.
The correlation of the burden of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with any revascularization at 1-year follow-up.
Time Frame: From enrollment to 1-year follow-up.
To correlate the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with any revascularization at 1-year follow-up.
From enrollment to 1-year follow-up.
Correlation of the burden of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with hospitalization for heart failure at 1-year follow-up.
Time Frame: From enrollment to 1-year follow-up.
To correlate the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with hospitalization for heart failure at 1-year follow-up.
From enrollment to 1-year follow-up.
Correlation of the burden of micro- and nanoplastics (MNPs) with major adverse cardiovascular events (cardiovascular death, myocardial infarction, any revascularization, hospitalization for heart failure) at 3-year follow-up.
Time Frame: From enrollment to 3-year follow-up.
To correlate the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with major adverse cardiovascular events (cardiovascular death, myocardial infarction, any revascularization, hospitalization for heart failure) at 3-year follow-up.
From enrollment to 3-year follow-up.
Correlation of the burden of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with all-cause death at 3-year follow-up.
Time Frame: From enrollment to 3-year follow-up.
To correlate the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with all-cause death at 3-year follow-up.
From enrollment to 3-year follow-up.
Correlation of the burden of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with cardiovascular death at 3-year follow-up.
Time Frame: From enrollment to 3-year follow-up.
To correlate the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with cardiovascular death at 3-year follow-up.
From enrollment to 3-year follow-up.
Correlation of the burden of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with myocardial infarction at 3-year follow-up.
Time Frame: From enrollment to 3-year follow-up.
To correlate the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with myocardial infarction at 3-year follow-up.
From enrollment to 3-year follow-up.
Correlation of the burden of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with any revascularization at 3-year follow-up.
Time Frame: From enrollment to 3-year follow-up.
To correlate the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with any revascularization at 3-year follow-up.
From enrollment to 3-year follow-up.
Correlation of the burden of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with hospitalization for heart failure at 3-year follow-up
Time Frame: From enrollment to 3-year follow-up.
To correlate the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with hospitalization for heart failure at 3-year follow-up
From enrollment to 3-year follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Azienda Ospedaliera "Sant'Andrea"

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Azienda Ospedaliera Universitaria Integrata Verona
Morgagni Pierantoni Hospital
Azienda Ospedaliera Sant'Anna e San Sebastiano
University of Campania Luigi Vanvitelli
Centro Cardiologico Monzino, Milan, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 24, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 18, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1000/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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