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

NCT ID: NCT06965023

Last Updated: 2025-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

130 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-22

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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ST-elevation Myocardial Infarction (STEMI) Microplastics Nanoplastics Pollution Exposure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

No interventions assigned to this group

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).

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Campania Luigi Vanvitelli

OTHER

Sponsor Role collaborator

Azienda Ospedaliera Universitaria Integrata Verona

OTHER

Sponsor Role collaborator

Morgagni Pierantoni Hospital

OTHER

Sponsor Role collaborator

Azienda Ospedaliera Sant'Anna e San Sebastiano

OTHER

Sponsor Role collaborator

University Hospital, Catania

OTHER

Sponsor Role collaborator

A.O.U. Città della Salute e della Scienza - Molinette Hospital

OTHER

Sponsor Role collaborator

Niguarda Hospital

OTHER

Sponsor Role collaborator

Azienda Ospedaliera Universitaria Ferrara

UNKNOWN

Sponsor Role collaborator

Azienda Ospedaliera "Sant'Andrea"

OTHER

Sponsor Role lead

Responsible Party

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Emanuele Barbato

Full Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pasquale Paolisso, MD, PhD

Role: STUDY_CHAIR

Sant'Andrea University Hospital

Marta Belmonte, MD

Role: STUDY_CHAIR

Sant'Andrea University Hospital

Locations

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Sant'Andrea University Hospital

Roma, Rome, Italy

Site Status RECRUITING

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

Caserta, , Italy

Site Status ACTIVE_NOT_RECRUITING

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

Caserta, , Italy

Site Status NOT_YET_RECRUITING

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

Catania, , Italy

Site Status NOT_YET_RECRUITING

Azienda Ospedaliero Universitaria di Ferrara, Cona, Italy

Ferrara, , Italy

Site Status NOT_YET_RECRUITING

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

Forlì, , Italy

Site Status NOT_YET_RECRUITING

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

Milan, , Italy

Site Status NOT_YET_RECRUITING

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

Naples, , Italy

Site Status ACTIVE_NOT_RECRUITING

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

Turin, , Italy

Site Status NOT_YET_RECRUITING

Azienda Ospedaliera Integrata Verona, Italy

Verona, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Emanuele Barbato, MD, PhD

Role: CONTACT

+39 0633776115 ext. +39 0633776115

Clinical Research Unit Cardiology Dept. Sant'Andrea University Hospital

Role: CONTACT

+39 0633778763

Facility Contacts

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Emanuele Barbato, MD, Phd

Role: primary

Clinical Research Unit

Role: backup

Paolo Calabrò

Role: primary

0823 178 3012

Davide Capodanno

Role: primary

095 7436103

Gianluca Campo

Role: primary

0532237079

Carmine Pizzi

Role: primary

+39 051 2144933

Luca Bergamaschi

Role: backup

Jacopo Andrea Oreglia

Role: primary

+39 02 64442308

Fabrizio D'Ascenzo

Role: primary

+39 3484760688

Flavio Ribichini

Role: primary

39 045 812 2039

Roberto Scarsini

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 38428296 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38614011 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39283932 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39164741 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36473237 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39240674 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38446676 (View on PubMed)

Other Identifiers

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0379/2025

Identifier Type: -

Identifier Source: org_study_id

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