Microplastics and Nanoplastics in Patients With Chronic Coronary Syndromes

Обзор

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.

Первичные конечные точки

• Burden of micro- and nanoplastics (MNPs) in the coronary blood of patients with chronic coronary syndromes (CCS) and obstructive coronary artery disease (CAD) [Срок оценки: 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. [Срок оценки: From enrollment until the date of hospital discharge, assessed up to 7 days]

Вторичные конечные точки (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). [Срок оценки: 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). [Срок оценки: 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). [Срок оценки: 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). [Срок оценки: 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). [Срок оценки: 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). [Срок оценки: 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. [Срок оценки: 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 [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: From enrollment to 1-year follow-up.]

Критерии участия

Критерии включения

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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 6 центров

• 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

Публикации

• 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

Идентификаторы

NCT: NCT07291609 · 1000/2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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