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

May 1, 2025 updated by: Emanuele Barbato, Azienda Ospedaliera "Sant'Andrea"
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Clinical Research Unit Cardiology Dept. Sant'Andrea University Hospital
  • Phone Number: +39 0633778763
  • Email: cru.cardiologia@uniroma1.it

Study Locations

  • Italy
      • Caserta, Italy
        • Active, not recruiting
        • Department of Environmental Biological and Pharmaceutical Sciences and Technologies, University of Campania "Luigi Vanvitelli
      • Caserta, Italy
        • Not yet recruiting
        • Division of Cardiology, A.O.R.N. "Sant'Anna e San Sebastiano", Caserta, Italy.
        • Sub-Investigator:
          • Felice Gragnano
        • Sub-Investigator:
          • Arturo Cesaro
        • Contact:
        • Principal Investigator:
          • Paolo Calabrò
        • Sub-Investigator:
          • Elisabetta Moscarella
      • Catania, Italy
        • Not yet recruiting
        • Cardiovascular Department, A.O.U. Policlinico "G. Rodolico - San Marco", University of Catania, Catania, Italy.
        • Contact:
        • Principal Investigator:
          • Davide Capodanno
      • Ferrara, Italy
        • Not yet recruiting
        • Azienda Ospedaliero Universitaria di Ferrara, Cona, Italy
        • Principal Investigator:
          • Gianluca Campo
        • Contact:
      • Forlì, Italy
        • Not yet recruiting
        • Cardiovascular Division, Morgagni-Pierantoni University Hospital, Forlì, Italy.
        • Sub-Investigator:
          • Luca Bergamaschi
        • Contact:
        • Contact:
        • Principal Investigator:
          • Carmine Pizzi
        • Sub-Investigator:
          • Matteo Armillotta
        • Sub-Investigator:
          • Francesco Angeli
        • Sub-Investigator:
          • Fabio Tarantino
        • Sub-Investigator:
          • Gianni Dall'Ara
      • Milan, Italy
        • Not yet recruiting
        • Interventional Cardiology Unit, De Gasperis Cardio Center, Niguarda Hospital, Milan, Italy.
        • Sub-Investigator:
          • Giuseppe Esposito
        • Contact:
        • Principal Investigator:
          • Jacopo Andrea Oreglia
        • Sub-Investigator:
          • Claudio Montalto
      • Naples, Italy
        • Active, not recruiting
        • Department of Advanced Medical and Surgical Sciences, University of Campania-Luigi Vanvitelli, Naples, Italy.
      • Turin, Italy
        • Not yet recruiting
        • Division of Cardiology, Cardiovascular and Thoracic Department, Città della Salute e della Scienza, Turin, Italy.
        • Contact:
        • Principal Investigator:
          • Fabrizio D'Ascenzo
        • Sub-Investigator:
          • Ovidio De Filippo
      • Verona, Italy
        • Recruiting
        • Azienda Ospedaliera Integrata Verona, Italy
        • Contact:
        • Contact:
        • Principal Investigator:
          • Flavio Ribichini
        • Sub-Investigator:
          • Roberto Scarsini
        • Sub-Investigator:
          • Verdiana Galli
    • Rome
      • Roma, Rome, Italy, 00189
        • Recruiting
        • Sant'Andrea University Hospital
        • Principal Investigator:
          • Emanuele Barbato
        • Sub-Investigator:
          • Pasquale Paolisso
        • Sub-Investigator:
          • Emanuele Gallinoro
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Marta Belmonte
        • Sub-Investigator:
          • Matteo Casenghi
        • Sub-Investigator:
          • Stefano Rigattieri

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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.
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.
From enrollment until the date of hospital discharge, assessed up to 7 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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).
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.
From enrollment until hospital discharge (up to 7 days from enrollment)
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.
From enrollment until hospital discharge (up to 7 days from enrollment).
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.
From enrollment until hospital discharge (up to 7 days from enrollment)
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.
From enrollment until hospital discharge (up to 7 days from enrollment)
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.
From enrollment until hospital discharge (up to 7 days from enrollment)
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.
From enrollment until hospital discharge (up to 7 days from enrollment)
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.
From enrollment until hospital discharge (up to 7 days from enrollment)
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.
From enrollment to follow-up.
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.
From enrollment until hospital discharge (up to 7 days from enrollment)
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).
From enrollment until hospital discharge (up to 7 days from enrollment)
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.
From enrollment until hospital discharge (up to 7 days from enrollment)
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).
From enrollment until hospital discharge (up to 7 days from enrollment)
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).
From enrollment until hospital discharge (up to 7 days from enrollment)
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.
From enrollment until hospital discharge (up to 7 days from enrollment)
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.
From enrollment until hospital discharge (up to 7 days from enrollment)
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.
From enrollment until hospital discharge (up to 7 days from enrollment)
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.
From enrollment to 3-month follow-up.
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.
From enrollment to 3-month follow-up.
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.
From enrollment to 1 year follow-up.
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.
From enrollment to 1 year follow-up.
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.
From enrollment to 1 year follow-up.
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.
From enrollment to 1 year follow-up.
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.
From enrollment to 1 year follow-up.
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.
From enrollment to 1 year follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Azienda Ospedaliera "Sant'Andrea"

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Azienda Ospedaliera Universitaria Integrata Verona
Niguarda Hospital
A.O.U. Città della Salute e della Scienza - Molinette Hospital
University Hospital, Catania
Morgagni Pierantoni Hospital
Azienda Ospedaliera Sant'Anna e San Sebastiano
Azienda Ospedaliera Universitaria Ferrara
University of Campania Luigi Vanvitelli

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Pasquale Paolisso, MD, PhD, Sant'Andrea University Hospital
  • Study Chair: Marta Belmonte, MD, Sant'Andrea University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 22, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 23, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 11, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0379/2025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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