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

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: Recruiting
• Conditions: Coronary Artery Disease; Computed Tomography; Chronic Coronary Syndrome; Microplastics; Nanoplastics; Pollution Exposure; Coronary Plaque

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Clinical Research Unit Cardiology Dept. Sant'Andrea University Hospital; Phone Number: +39 0633778763; Email: cru.cardiologia@uniroma1.it
• Study Contact Backup: Name: Emanuele Barbato, MD, PhD; Phone Number: +39 0633776115; Email: emanuele.barbato@uniroma1.it

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: Paolo Calabrò, MD, Phd; Phone Number: +3908231783012; Email: paolo.calabro@unicampania.it
  • Forlì, Italy
    • Not yet recruiting
    • Cardiovascular Division, Morgagni-Pierantoni University Hospital, Forlì, Italy.
    • Contact: Carmine Pizzi, MD, Phd; Phone Number: +39 051 2144933; Email: carmine.pizzi@unibo.it
    • Sub-Investigator: Luca Bergamaschi, MD, PhD
    • Sub-Investigator: Matteo Armillotta, MD
    • Sub-Investigator: Francesco Angeli, MD
  • Milan, Italy
    • Active, not recruiting
    • Centro Cardiologico Monzino
  • Napoli, 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: Emanuele Barbato, MD, Phd; Phone Number: +390633776115; Email: emanuele.barbato@uniroma1.it
    • Contact: Clinical Research Unit; Phone Number: +390633778763; Email: cru.cardiologia@uniroma1.it
    • 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: Flavio Ribichini, MD, Phd; Email: flavio.ribichini@univr.it
    • Sub-Investigator: Roberto Scarsini, MD, PhD

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

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)	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.	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

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).	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).	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).	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).	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).	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).	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.	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	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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	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

• Sponsor: Azienda Ospedaliera "Sant'Andrea"
• Collaborators: 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

General Publications

• Liu S, Wang C, Yang Y, Du Z, Li L, Zhang M, Ni S, Yue Z, Yang K, Wang Y, Li X, Yang Y, Qin Y, Li J, Yang Y, Zhang M. Microplastics in three types of human arteries detected by pyrolysis-gas chromatography/mass spectrometry (Py-GC/MS). J Hazard Mater. 2024 May 5;469:133855. doi: 10.1016/j.jhazmat.2024.133855. Epub 2024 Feb 21.
• Wang T, Yi Z, Liu X, Cai Y, Huang X, Fang J, Shen R, Lu W, Xiao Y, Zhuang W, Guo S. Multimodal detection and analysis of microplastics in human thrombi from multiple anatomically distinct sites. EBioMedicine. 2024 May;103:105118. doi: 10.1016/j.ebiom.2024.105118. Epub 2024 Apr 13.
• Lee DH. Microplastics and Cardiovascular Diseases: Importance of Coexisting Environmental Pollutants. Circulation. 2024 Sep 17;150(12):908-910. doi: 10.1161/CIRCULATIONAHA.124.069801. Epub 2024 Sep 16. No abstract available.
• Prattichizzo F, Ceriello A, Pellegrini V, La Grotta R, Graciotti L, Olivieri F, Paolisso P, D'Agostino B, Iovino P, Balestrieri ML, Rajagopalan S, Landrigan PJ, Marfella R, Paolisso G. Micro-nanoplastics and cardiovascular diseases: evidence and perspectives. Eur Heart J. 2024 Oct 7;45(38):4099-4110. doi: 10.1093/eurheartj/ehae552.
• Marfella R, Prattichizzo F, Sardu C, Fulgenzi G, Graciotti L, Spadoni T, D'Onofrio N, Scisciola L, La Grotta R, Frige C, Pellegrini V, Municino M, Siniscalchi M, Spinetti F, Vigliotti G, Vecchione C, Carrizzo A, Accarino G, Squillante A, Spaziano G, Mirra D, Esposito R, Altieri S, Falco G, Fenti A, Galoppo S, Canzano S, Sasso FC, Matacchione G, Olivieri F, Ferraraccio F, Panarese I, Paolisso P, Barbato E, Lubritto C, Balestrieri ML, Mauro C, Caballero AE, Rajagopalan S, Ceriello A, D'Agostino B, Iovino P, Paolisso G. Microplastics and Nanoplastics in Atheromas and Cardiovascular Events. N Engl J Med. 2024 Mar 7;390(10):900-910. doi: 10.1056/NEJMoa2309822.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: November 24, 2025
• First Submitted That Met QC Criteria: December 5, 2025
• First Posted (Actual): December 18, 2025

Study Record Updates

• Last Update Posted (Actual): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 5, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID 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