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ST-elevation Myocardial Infarction (STEMI)STEMI-PlasticsNCT06965023

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

An observational study of ST-elevation Myocardial Infarction (STEMI) and Microplastics, run by Azienda Ospedaliera "Sant'Andrea" at 10 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
130 participants
Where
10 sitesItaly
Study dates
22 Apr 2025to 31 Dec 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

10 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Emanuele Barbato, MD, PhD contact

+39 0633776115 ext. +39 0633776115

emanuele.barbato@uniroma1.it

Clinical Research Unit Cardiology Dept. Sant'Andrea University Hospital contact

+39 0633778763

cru.cardiologia@uniroma1.it

10 sites in 1 country

Italy10 sites, 8 recruiting

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

    Caserta

    Active, not recruiting

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

    Caserta

    Paolo Calabrò, 0823 178 3012, paolo.calabro@unicampania.it

    Paolo Calabrò

    Not yet recruiting

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

    Catania

    Davide Capodanno, 095 7436103, dcapodanno@unict.it

    Davide Capodanno

    Not yet recruiting

  • Azienda Ospedaliero Universitaria di Ferrara, Cona, Italy

    Ferrara

    Gianluca Campo, 0532237079, gianlucacampo@unife.it

    Gianluca Campo

    Not yet recruiting

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

    Forlì

    Carmine Pizzi, +39 051 2144933, carmine.pizzi@unibo.it

    Luca Bergamaschi, lucabergamaschi91@gmail.com

    Not yet recruiting

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

    Milan

    Jacopo Andrea Oreglia, +39 02 64442308, jacopo.oreglia@ospedaleniguarda.it

    Jacopo Andrea Oreglia

    Not yet recruiting

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

    Naples

    Active, not recruiting

  • Sant'Andrea University Hospital

    Roma, Rome, 00189

    Emanuele Barbato, MD, Phd, emanuele.barbato@uniroma1.it

    Clinical Research Unit, cru.cardiologia@uniroma1.it

    Recruiting

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

    Turin

    Fabrizio D'Ascenzo, +39 3484760688, fabrizio.dascenzo@gmail.com

    Fabrizio D'Ascenzo

    Not yet recruiting

  • Azienda Ospedaliera Integrata Verona, Italy

    Verona

    Flavio Ribichini, 39 045 812 2039, flavio.ribichini@univr.it

    Roberto Scarsini, roberto.scarsini@univr.it

    Recruiting

Other trials in Italy

About this study

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.

Keywords
STEMI, Microplastics, Nanoplastics, Inflammation, OCT, Plaque composition, cardiac magnetic resonance, Pollution, Exposome, Infarct Size, Coronary Microvascular Dysfunction, IMR, MRR
Medical subject headings
ST Elevation Myocardial Infarction, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06965023
Study groupRoleWhat they receive
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).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

Secondary outcomes (25)

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

    To assess the difference in the burden of micro- and nanoplastics (MNPs) between the culprit coronary artery and the contralateral coronary artery.

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

  2. Age- and sex- related differences in the burden of micro- and nanoplastics (MNPs).

    To evaluate the variation in the burden of micro- and nanoplastics (MNPs) based on sex and across different age groups.

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

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

    To evaluate the variation in the burden of micro- and nanoplastics (MNPs) across different geographic regions.

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

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

    To correlate the burden of micro- and nanoplastics (MNPs) with air pollution across different geographic regions.

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

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

    To assess differences in the burden of micro- and nanoplastics (MNPs) across venous blood, arterial blood, and urine samples.

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

  6. Micro- and nanoplastics (MNPs) in diabetic vs. non-diabetic patients.

    To assess the difference in the burden of micro- and nanoplastics (MNPs) between diabetic and non-diabetic patients.

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

  7. Micro- and nanoplastics (MNPs) in patients with and without chronic kidney disease.

    To assess the difference in the burden of micro- and nanoplastics (MNPs) between patients with and without chronic kidney disease.

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

  8. Micro- and nanoplastics (MNPs) clearance in patients with and without chronic kidney disease.

    To evaluate the clearance of micro- and nanoplastics (MNPs) assessed through plasma and urine concentration measurements of MNPs in patients with and without chronic kidney disease.

    The clearance of MNPs will be quantified by comparing concentrations of identified micro- and nanoplastics in plasma and urine samples collected at the defined time points. Clearance will be estimated based on MNP plasma decay curves and cumulative urinary excretion.

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

  9. Variation in the burden of micro- and nanoplastics (MNPs) between baseline and follow-up.

    To evaluate the variation in the burden of micro- and nanoplastics (MNPs) between baseline and follow-up in venous blood samples.

    Measured: From enrollment to follow-up.

  10. Association of the burden of micro- and nanoplastics (MNPs) with coronary reperfusion.

    To correlate the burden of micro- and nanoplastics (MNPs) with the success of coronary reperfusion as assessed by TIMI flow and MBG at invasive coronary angiography.

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

  11. Association of the burden of micro- and nanoplastics (MNPs) with plaque composition as assessed by optical coherence tomography (OCT).

    To correlate the burden of micro- and nanoplastics (MNPs) in coronary thromboaspirate with plaque composition as assessed by intravascular imaging (optical coherence tomography - OCT).

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

  12. Association of the burden of micro- and nanoplastics (MNPs) with microvascular dysfunction/obstruction post PCI as assessed by invasive bolus thermodilution.

    To correlate the burden of micro- and nanoplastics (MNPs) with microvascular dysfunction/obstruction post percutaneous coronary intervention as assessed by invasive bolus thermodilution.

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

  13. 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).

    To correlate the burden of micro- and nanoplastics (MNPs) with infarct size, myocardial area at risk, microvascular obstruction, and intramyocardial hemorrhage as assessed by cardiac magnetic resonance (CMR).

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

  14. Association of the burden of micro- and nanoplastics (MNPs) with peak Troponin.

    To correlate the burden of micro- and nanoplastics (MNPs) in coronary thromboaspirate with the peak value of high-sensitivity troponin (hs-Tn).

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

  15. Association of the burden of micro- and nanoplastics (MNPs) with left ventricular ejection fraction and wall motion score index at echocardiography.

    To correlate the burden of micro- and nanoplastics (MNPs) in coronary thromboaspirate with left ventricular ejection fraction and wall motion score index as assessed by echocardiography at hospital admission and discharge.

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

  16. Association of the burden of micro- and nanoplastics (MNPs) with in-hospital arrhythmic burden.

    To correlate the burden of micro- and nanoplastics (MNPs) in coronary thromboaspirate with the in-hospital arrhythmic burden.

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

  17. Association of the burden of micro- and nanoplastics (MNPs) with in-hospital cardiovascular death.

    To correlate the burden of micro- and nanoplastics (MNPs) in coronary thromboaspirate with in-hospital cardiovascular death.

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

  18. Association of the burden of micro- and nanoplastics (MNPs) with left ventricular recovery at 3 months follow-up.

    To correlate the burden of micro- and nanoplastics (MNPs) in coronary thromboaspirate with left ventricular recovery at 3-month follow-up as assessed by echocardiography.

    Measured: From enrollment to 3-month follow-up.

  19. Association of the burden of micro- and nanoplastics (MNPs) with recurrence angina at 3-month follow-up.

    To correlate the burden of micro- and nanoplastics (MNPs) in coronary thromboaspirate with the recurrence of angina at 3-month follow-up.

    Measured: From enrollment to 3-month follow-up.

  20. Association of the burden of micro- and nanoplastics (MNPs) with all-cause death at 1-year follow-up.

    To correlate the burden of micro- and nanoplastics (MNPs) in coronary thromboaspirate with all-cause death at 1-year follow-up.

    Measured: From enrollment to 1 year follow-up.

  21. Association of the burden of micro- and nanoplastics (MNPs) with cardiovascular death at 1-year follow-up.

    To correlate the burden of micro- and nanoplastics (MNPs) in coronary thromboaspirate with cardiovascular death at 1-year follow-up.

    Measured: From enrollment to 1 year follow-up.

  22. Association of the burden of micro- and nanoplastics (MNPs) with hospitalization for heart failure at 1-year follow-up.

    To correlate the burden of micro- and nanoplastics (MNPs) in coronary thromboaspirate with hospitalization for heart failure at 1-year follow-up.

    Measured: From enrollment to 1 year follow-up.

  23. Association of the burden of micro- and nanoplastics (MNPs) with the recurrence of myocardial infarction at 1-year follow-up.

    To correlate the burden of micro- and nanoplastics (MNPs) in coronary thromboaspirate with the recurrence of myocardial infarction at 1-year follow-up.

    Measured: From enrollment to 1 year follow-up.

  24. Association of the burden of micro- and nanoplastics (MNPs) with target vessel failure at 1-year follow-up.

    To correlate the burden of micro- and nanoplastics (MNPs) in coronary thromboaspirate with target vessel failure at 1-year follow-up.

    Measured: From enrollment to 1 year follow-up.

  25. Association of the burden of micro- and nanoplastics (MNPs) with major adverse cardiovascular events (MACE) at 1-year follow-up.

    To correlate the burden of micro- and nanoplastics (MNPs) in coronary thromboaspirate with major adverse cardiovascular events (MACE) at 1-year follow-up.

    Measured: From enrollment to 1 year follow-up.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2025
  2. Study start22 Apr 2025
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
130 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06965023
Sponsor's protocol ID
0379/2025
Acronym
STEMI-Plastics
Status last verified
May 2025
First submitted
23 Apr 2025
Last updated
11 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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, 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.

    PubMed 38446676

Questions about this trial

What is this clinical trial studying?

An observational study of ST-elevation Myocardial Infarction (STEMI) and Microplastics, run by Azienda Ospedaliera "Sant'Andrea" at 10 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Emanuele Barbato, MD, PhD (+39 0633776115 ext. +39 0633776115, emanuele.barbato@uniroma1.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Burden of micro- and nanoplastics (MNPs) in coronary thromboaspirate in STEMI patients. (time frame: From enrollment until the date of hospital discharge, assessed up to 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06965023, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2025.

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