Microplastics and Nanoplastics (MNPs) in Patients With ST-elevation Myocardial Infarction (STEMI)

Обзор

Air pollution and microplastics pose major public health threats. Emerging data have shown that micro- and nanoplastics (MNPs) are ubiquitous environmental pollutants accumulating in human tissues, triggering inflammation and prothrombotic state. This study will investigate the presence and burden of MNPs within coronary thrombi/thromboaspirate of patients presenting with ST segment elevation acute myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention and their association with cardiac damage, plaque vulnerability, microvascular obstruction, and cardiovascular events. Plaque vulnerability will be explored by optical coherence tomography, while microvascular obstruction will be assessed by bolus thermodilution and cardiac magnetic resonance. Participants will be followed up for 1-year to evaluate whether the presence and the burden of MNPs will be associated with a higher incidence of the cardiovascular events.

Первичные конечные точки

• Burden of micro- and nanoplastics (MNPs) in coronary thromboaspirate in STEMI patients. [Срок оценки: From enrollment until the date of hospital discharge, assessed up to 7 days]
• Correlation of micro- and nanoplastics (MNPs) in coronary thromboaspirate in STEMI patients with inflammatory and cardiac damage biomarkers. [Срок оценки: From enrollment until the date of hospital discharge, assessed up to 7 days]

Вторичные конечные точки (12)

• Burden of micro- and nanoplastics (MNPs) in culprit vs. non-culprit vessels. [Срок оценки: From enrollment until the date of hospital discharge, assessed up to 7 days]
• Age- and sex- related differences in the burden of micro- and nanoplastics (MNPs). [Срок оценки: From enrollment until hospital discharge (up to 7 days from enrollment)]
• Burden of micro- and nanoplastics (MNPs) in STEMI patients across different geographic regions. [Срок оценки: From enrollment until hospital discharge (up to 7 days from enrollment).]
• Association of burden of micro- and nanoplastics (MNPs) with air pollution. [Срок оценки: From enrollment until hospital discharge (up to 7 days from enrollment)]
• Differences in the burden of micro- and nanoplastics (MNPs) across biological samples. [Срок оценки: From enrollment until hospital discharge (up to 7 days from enrollment)]
• Micro- and nanoplastics (MNPs) in diabetic vs. non-diabetic patients. [Срок оценки: From enrollment until hospital discharge (up to 7 days from enrollment)]
• Micro- and nanoplastics (MNPs) in patients with and without chronic kidney disease. [Срок оценки: From enrollment until hospital discharge (up to 7 days from enrollment)]
• Micro- and nanoplastics (MNPs) clearance in patients with and without chronic kidney disease. [Срок оценки: From enrollment until hospital discharge (up to 7 days from enrollment)]
• Variation in the burden of micro- and nanoplastics (MNPs) between baseline and follow-up. [Срок оценки: From enrollment to follow-up.]
• Association of the burden of micro- and nanoplastics (MNPs) with coronary reperfusion. [Срок оценки: From enrollment until hospital discharge (up to 7 days from enrollment)]
• Association of the burden of micro- and nanoplastics (MNPs) with plaque composition as assessed by optical coherence tomography (OCT). [Срок оценки: From enrollment until hospital discharge (up to 7 days from enrollment)]
• Association of the burden of micro- and nanoplastics (MNPs) with microvascular dysfunction/obstruction post PCI as assessed by invasive bolus thermodilution. [Срок оценки: From enrollment until hospital discharge (up to 7 days from enrollment)]

Критерии участия

Критерии включения

All the following inclusion criteria should be fulfilled:

• Age > 18 years old;
• STEMI undergoing urgent invasive coronary angiography;
• Acute thrombotic coronary occlusion/sub-occlusion (TIMI 0/1);
• Clinical indication to thromboaspiration;
• Able to give informed consent.

Критерии исключения

• Contraindications to percutaneous coronary intervention;
• Hemodynamic instability or cardiogenic shock;
• End-stage chronic kidney disease;
• 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 · 10 центров

• Sant'Andrea University Hospital — Roma
• Department of Environmental Biological and Pharmaceutical Sciences and Technologies, Unive — Caserta
• Division of Cardiology, A.O.R.N. "Sant'Anna e San Sebastiano", Caserta, Italy. — Caserta
• Cardiovascular Department, A.O.U. Policlinico "G. Rodolico - San Marco", University of Cat — Catania
• Azienda Ospedaliero Universitaria di Ferrara, Cona, Italy — Ferrara
• Cardiovascular Division, Morgagni-Pierantoni University Hospital, Forlì, Italy. — Forlì
• Interventional Cardiology Unit, De Gasperis Cardio Center, Niguarda Hospital, Milan, Italy — Milan
• Department of Advanced Medical and Surgical Sciences, University of Campania-Luigi Vanvite — Naples
• … и ещё 2 центра

Публикации

• 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
• 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
• 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
• Yang Y, Zhang F, Jiang Z, Du Z, Liu S, Zhang M, Jin Y, Qin Y, Yang X, Wang C, Gao H. Microplastics are associated with elevated atherosclerotic risk and increased vascular complexity in acute coronary syndrome patients. Part Fibre Toxicol. 2024 Aug 21;21(1):34. doi: 10.1186/s12989-024-00596-4. PMID 39164741
• Zhu X, Wang C, Duan X, Liang B, Genbo Xu E, Huang Z. Micro- and nanoplastics: A new cardiovascular risk factor? Environ Int. 2023 Jan;171:107662. doi: 10.1016/j.envint.2022.107662. Epub 2022 Nov 26. PMID 36473237
• 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
• 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

Идентификаторы

NCT: NCT06965023 · 0379/2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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