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Recruiting NCT07291609

Microplastics and Nanoplastics in Patients With Chronic Coronary Syndromes

— Observational Chronic Coronary Syndrome Microplastics Nanoplastics Coronary Artery Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Chronic Coronary Syndrome, Microplastics, Nanoplastics, Coronary Artery Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Primary outcome measures

  • 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]
  • 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]
Secondary outcome measures (12)
  • 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.]
  • 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]
  • 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]
  • 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]
  • 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.]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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.]
  • 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.]
  • 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.]

Eligibility criteria

Inclusion criteria

ALL the following:

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 6 centers
  • Division of Cardiology, A.O.R.N. "Sant'Anna e San Sebastiano", Caserta, Italy. — Caserta
  • Cardiovascular Division, Morgagni-Pierantoni University Hospital, Forlì, Italy. — Forlì
  • Centro Cardiologico Monzino — Milan
  • Department of Advanced Medical and Surgical Sciences, University of Campania-Luigi Vanvite — Naples
  • Sant'Andrea University Hospital — Roma
  • Azienda Ospedaliera Integrata Verona, Italy — Verona

Publications

  • 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. PMID 39283932
  • 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. PMID 38614011
  • 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, Ba PMID 38446676
  • 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. PMID 39240674
  • 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. PMID 38428296

Identifiers

NCT: NCT07291609 · 1000/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗