Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06965023

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

ST-elevation Myocardial Infarction (STEMI) Cardiovascular Diseases Heart Diseases Infarction Inflammation Ischemia Microplastics Myocardial Infarction Myocardial Ischemia Nanoplastics Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Pollution Exposure ST Elevation Myocardial Infarction Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sant'Andrea University Hospital, Roma, Rome, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 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

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

  2. Correlation of micro- and nanoplastics (MNPs) in coronary thromboaspirate in STEMI patients with inflammatory and cardiac damage biomarkers.

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

    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.

Secondary outcomes

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    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.

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

    Time frame: From enrollment to follow-up.

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

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

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

    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.

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

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

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

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

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

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

  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).

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

    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).

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

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

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

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

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

    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.

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

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

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

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

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

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

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

    Time frame: From enrollment to 3-month 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.

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

    Time frame: From enrollment to 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.

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

    Time frame: From enrollment to 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.

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

    Time frame: From enrollment to 1 year follow-up.

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

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

    Time frame: From enrollment to 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.

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

    Time frame: From enrollment to 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.

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

    Time frame: From enrollment to 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.

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

    Time frame: From enrollment to 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Research Unit Cardiology Dept. Sant'Andrea University Hospital

CONTACT

[email protected]

+39 0633778763

Emanuele Barbato, MD, PhD

CONTACT

[email protected]

+39 0633776115 ext. +39 0633776115

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera "Sant'Andrea"

Other

Collaborators

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

Registry information

Acronym: STEMI-Plastics

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
May 11, 2025
Registry last updated
May 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.