Clinical trial NCT06965023: Microplastics and Nanoplastics (MNPs) in Patients With ST-elevation Myocardial Infarction (STEMI)
Official title: Microplastics and Nanoplastics (MNPs) in Patients With ST-elevation Myocardial Infarction (STEMI)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: ST-elevation Myocardial Infarction (STEMI)
Microplastics
Nanoplastics
Pollution Exposure
Keywords: STEMI
Microplastics
Nanoplastics
Inflammation
OCT
Plaque composition
cardiac magnetic resonance
Pollution
Exposome
Infarct Size
Coronary Microvascular Dysfunction
IMR
MRR
Lead sponsor: Azienda Ospedaliera "Sant'Andrea"
Sponsor class: OTHER
Collaborators: name: University of Campania Luigi Vanvitelli
name: Azienda Ospedaliera Universitaria Integrata Verona
name: Morgagni Pierantoni Hospital
name: Azienda Ospedaliera Sant'Anna e San Sebastiano
name: University Hospital, Catania
name: A.O.U. Città della Salute e della Scienza - Molinette Hospital
name: Niguarda Hospital
name: Azienda Ospedaliera Universitaria Ferrara
First posted: 2025-05-11
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients with ST-elevation myocardial infarction (STEMI) undergoing urgent invasive coronary angiography with evidence of acute thrombotic coronary occlusion/sub-occlusion and clinical indication to thromboaspiration will be considered eligible for inclusion in the study.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

All the following inclusion criteria should be fulfilled:

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

Exclusion Criteria:

1. Contraindications to percutaneous coronary intervention;
2. Hemodynamic instability or cardiogenic shock;
3. End-stage chronic kidney disease;
4. Life expectancy \< 1 year due to non-cardiac pathology.

Primary outcomes:
measure: Burden of micro- and nanoplastics (MNPs) in coronary thromboaspirate in STEMI patients.
timeFrame: From enrollment until the date of hospital discharge, assessed up to 7 days
measure: Correlation of micro- and nanoplastics (MNPs) in coronary thromboaspirate in STEMI patients with inflammatory and cardiac damage biomarkers.
timeFrame: From enrollment until the date of hospital discharge, assessed up to 7 days
Secondary outcomes:
measure: Burden of micro- and nanoplastics (MNPs) in culprit vs. non-culprit vessels.
timeFrame: From enrollment until the date of hospital discharge, assessed up to 7 days
measure: Age- and sex- related differences in the burden of micro- and nanoplastics (MNPs).
timeFrame: From enrollment until hospital discharge (up to 7 days from enrollment)
measure: Burden of micro- and nanoplastics (MNPs) in STEMI patients across different geographic regions.
timeFrame: From enrollment until hospital discharge (up to 7 days from enrollment).
measure: Association of burden of micro- and nanoplastics (MNPs) with air pollution.
timeFrame: From enrollment until hospital discharge (up to 7 days from enrollment)
measure: Differences in the burden of micro- and nanoplastics (MNPs) across biological samples.
timeFrame: From enrollment until hospital discharge (up to 7 days from enrollment)
measure: Micro- and nanoplastics (MNPs) in diabetic vs. non-diabetic patients.
timeFrame: From enrollment until hospital discharge (up to 7 days from enrollment)
measure: Micro- and nanoplastics (MNPs) in patients with and without chronic kidney disease.
timeFrame: From enrollment until hospital discharge (up to 7 days from enrollment)
measure: Micro- and nanoplastics (MNPs) clearance in patients with and without chronic kidney disease.
timeFrame: From enrollment until hospital discharge (up to 7 days from enrollment)
measure: Variation in the burden of micro- and nanoplastics (MNPs) between baseline and follow-up.
timeFrame: From enrollment to follow-up.
measure: Association of the burden of micro- and nanoplastics (MNPs) with coronary reperfusion.
timeFrame: From enrollment until hospital discharge (up to 7 days from enrollment)
measure: Association of the burden of micro- and nanoplastics (MNPs) with plaque composition as assessed by optical coherence tomography (OCT).
timeFrame: From enrollment until hospital discharge (up to 7 days from enrollment)
measure: Association of the burden of micro- and nanoplastics (MNPs) with microvascular dysfunction/obstruction post PCI as assessed by invasive bolus thermodilution.
timeFrame: From enrollment until hospital discharge (up to 7 days from enrollment)
measure: Association of the burden of micro- and nanoplastics (MNPs) with infarct size, myocardial area at risk, microvascular obstruction, and intramyocardial hemorrhage at cardiac magnetic resonance (CMR).
timeFrame: From enrollment until hospital discharge (up to 7 days from enrollment)
measure: Association of the burden of micro- and nanoplastics (MNPs) with peak Troponin.
timeFrame: From enrollment until hospital discharge (up to 7 days from enrollment)
measure: Association of the burden of micro- and nanoplastics (MNPs) with left ventricular ejection fraction and wall motion score index at echocardiography.
timeFrame: From enrollment until hospital discharge (up to 7 days from enrollment)
measure: Association of the burden of micro- and nanoplastics (MNPs) with in-hospital arrhythmic burden.
timeFrame: From enrollment until hospital discharge (up to 7 days from enrollment)
measure: Association of the burden of micro- and nanoplastics (MNPs) with in-hospital cardiovascular death.
timeFrame: From enrollment until hospital discharge (up to 7 days from enrollment)
measure: Association of the burden of micro- and nanoplastics (MNPs) with left ventricular recovery at 3 months follow-up.
timeFrame: From enrollment to 3-month follow-up.
measure: Association of the burden of micro- and nanoplastics (MNPs) with recurrence angina at 3-month follow-up.
timeFrame: From enrollment to 3-month follow-up.
measure: Association of the burden of micro- and nanoplastics (MNPs) with all-cause death at 1-year follow-up.
timeFrame: From enrollment to 1 year follow-up.
measure: Association of the burden of micro- and nanoplastics (MNPs) with cardiovascular death at 1-year follow-up.
timeFrame: From enrollment to 1 year follow-up.
measure: Association of the burden of micro- and nanoplastics (MNPs) with hospitalization for heart failure at 1-year follow-up.
timeFrame: From enrollment to 1 year follow-up.
measure: Association of the burden of micro- and nanoplastics (MNPs) with the recurrence of myocardial infarction at 1-year follow-up.
timeFrame: From enrollment to 1 year follow-up.
measure: Association of the burden of micro- and nanoplastics (MNPs) with target vessel failure at 1-year follow-up.
timeFrame: From enrollment to 1 year follow-up.
measure: Association of the burden of micro- and nanoplastics (MNPs) with major adverse cardiovascular events (MACE) at 1-year follow-up.
timeFrame: From enrollment to 1 year follow-up.
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Sant'Andrea University Hospital
state: Rome
city: Caserta
country: Italy
facility: Department of Environmental Biological and Pharmaceutical Sciences and Technologies, University of Campania "Luigi Vanvitelli
city: Caserta
country: Italy
facility: Division of Cardiology, A.O.R.N. "Sant'Anna e San Sebastiano", Caserta, Italy.
city: Catania
country: Italy
facility: Cardiovascular Department, A.O.U. Policlinico "G. Rodolico - San Marco", University of Catania, Catania, Italy.
city: Ferrara
country: Italy
facility: Azienda Ospedaliero Universitaria di Ferrara, Cona, Italy
city: Forlì
country: Italy
facility: Cardiovascular Division, Morgagni-Pierantoni University Hospital, Forlì, Italy.
city: Milan
country: Italy
facility: Interventional Cardiology Unit, De Gasperis Cardio Center, Niguarda Hospital, Milan, Italy.
city: Naples
country: Italy
facility: Department of Advanced Medical and Surgical Sciences, University of Campania-Luigi Vanvitelli, Naples, Italy.
city: Turin
country: Italy
facility: Division of Cardiology, Cardiovascular and Thoracic Department, Città della Salute e della Scienza, Turin, Italy.
city: Verona
country: Italy
facility: Azienda Ospedaliera Integrata Verona, Italy
Study officials:
affiliation: Sant'Andrea University Hospital
name: Pasquale Paolisso, MD, PhD
role: STUDY_CHAIR
affiliation: Sant'Andrea University Hospital
name: Marta Belmonte, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.