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

NCT06965023 | Recruiting DMC

• 1 other identifier: 0379/2025
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 10

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.

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

Outcome Measures

Primary Outcomes (2)

• Burden of micro- and nanoplastics (MNPs) in coronary thromboaspirate in STEMI patients.

  To assess the burden of micro- and nanoplastics (MNPs) in coronary thromboaspirate of patients experiencing an ST-elevation myocardial infarction.

  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.

  To assess the correlation between the burden of micro- and nanoplastics (MNPs) in coronary thromboaspirate of patients experiencing an ST-elevation myocardial infarction with inflammatory, oxidative stress, and cardiac damage biomarkers of peripheral and coronary blood samples.

  From enrollment until the date of hospital discharge, assessed up to 7 days

Secondary Outcomes (25)

• Burden of micro- and nanoplastics (MNPs) in culprit vs. non-culprit vessels.

  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).

  From enrollment until hospital discharge (up to 7 days from enrollment)

• Burden of micro- and nanoplastics (MNPs) in STEMI patients across different geographic regions.

  From enrollment until hospital discharge (up to 7 days from enrollment).

• Association of burden of micro- and nanoplastics (MNPs) with air pollution.

  From enrollment until hospital discharge (up to 7 days from enrollment)

• Differences in the burden of micro- and nanoplastics (MNPs) across biological samples.

  From enrollment until hospital discharge (up to 7 days from enrollment)

Study Arms (2)

STEMI patients with presence of micro- and nano-plastics (MNPs).

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 with the presence of micro- and nano-plastics (MNPs).

STEMI patients without presence of micro- and nano-plastics (MNPs)

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 without the presence of micro- and nano-plastics (MNPs).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Azienda Ospedaliera "Sant'Andrea": lead
• University of Campania Luigi Vanvitelli: collaborator
• Azienda Ospedaliera Universitaria Integrata Verona: collaborator
• Morgagni Pierantoni Hospital: collaborator
• Azienda Ospedaliera Sant'Anna e San Sebastiano: collaborator
• University Hospital, Catania: collaborator
• A.O.U. Città della Salute e della Scienza - Molinette Hospital: collaborator
• Niguarda Hospital: collaborator
• Azienda Ospedaliera Universitaria Ferrara: collaborator

Study Sites (10)

Sant'Andrea University Hospital

Roma, Rome, 00189, Italy

RECRUITING

Department of Environmental Biological and Pharmaceutical Sciences and Technologies, University of Campania "Luigi Vanvitelli

Caserta, Italy

ACTIVE NOT RECRUITING

Division of Cardiology, A.O.R.N. "Sant'Anna e San Sebastiano", Caserta, Italy.

Caserta, Italy

NOT YET RECRUITING

Cardiovascular Department, A.O.U. Policlinico "G. Rodolico - San Marco", University of Catania, Catania, Italy.

Catania, Italy

NOT YET RECRUITING

Azienda Ospedaliero Universitaria di Ferrara, Cona, Italy

Ferrara, Italy

NOT YET RECRUITING

Cardiovascular Division, Morgagni-Pierantoni University Hospital, Forlì, Italy.

Forlì, Italy

NOT YET RECRUITING

Interventional Cardiology Unit, De Gasperis Cardio Center, Niguarda Hospital, Milan, Italy.

Milan, Italy

NOT YET RECRUITING

Department of Advanced Medical and Surgical Sciences, University of Campania-Luigi Vanvitelli, Naples, Italy.

Naples, Italy

ACTIVE NOT RECRUITING

Division of Cardiology, Cardiovascular and Thoracic Department, Città della Salute e della Scienza, Turin, Italy.

Turin, Italy

NOT YET RECRUITING

Azienda Ospedaliera Integrata Verona, Italy

Verona, Italy

RECRUITING

Related Publications (7)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 38446676 BACKGROUND

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Inflammation

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Pasquale Paolisso, MD, PhD

  Sant'Andrea University Hospital

  STUDY CHAIR

• Marta Belmonte, MD

  Sant'Andrea University Hospital

  STUDY CHAIR

Central Study Contacts

Emanuele Barbato, MD, PhD

CONTACT

+39 0633776115; emanuele.barbato@uniroma1.it

Clinical Research Unit Cardiology Dept. Sant'Andrea University Hospital

CONTACT

+39 0633778763; cru.cardiologia@uniroma1.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: May 11, 2025
• Study Start: April 22, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 11, 2025

Record last verified: 2025-05

Locations

IT (10)