An observational study in ST-elevation Myocardial Infarction (STEMI), Microplastics and Nanoplastics, sponsored by Azienda Ospedaliera "Sant'Andrea". Recruiting at 10 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-11.
Sponsored by Azienda Ospedaliera "Sant'Andrea" · Observational
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.
850 studies on the registry are indexed under ST Elevation Myocardial Infarction; 197 are open to participants now.
This study's planned enrollment of 130 is below the median of 335 across 297 observational studies indexed under ST Elevation Myocardial Infarction.
Browse ST Elevation Myocardial Infarction studies →Azienda Ospedaliera "Sant'Andrea" is the lead sponsor of 7 studies on the registry; 3 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
All the following inclusion criteria should be fulfilled:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
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).
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.
Time frame: 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.
Time frame: From enrollment until the date of hospital discharge, assessed up to 7 days
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.
Time frame: 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).
To evaluate the variation in the burden of micro- and nanoplastics (MNPs) based on sex and across different age groups.
Time frame: From enrollment until hospital discharge (up to 7 days from enrollment)
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.
Time frame: From enrollment until hospital discharge (up to 7 days from enrollment).
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.
Time frame: From enrollment until hospital discharge (up to 7 days from enrollment)
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.
Time frame: From enrollment until hospital discharge (up to 7 days from enrollment)
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.
Time frame: From enrollment until hospital discharge (up to 7 days from enrollment)
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.
Time frame: From enrollment until hospital discharge (up to 7 days from enrollment)
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.
Time frame: 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.
To evaluate the variation in the burden of micro- and nanoplastics (MNPs) between baseline and follow-up in venous blood samples.
Time frame: From enrollment to follow-up.
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.
Time frame: 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).
To correlate the burden of micro- and nanoplastics (MNPs) in coronary thromboaspirate with plaque composition as assessed by intravascular imaging (optical coherence tomography - OCT).
Time frame: 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.
To correlate the burden of micro- and nanoplastics (MNPs) with microvascular dysfunction/obstruction post percutaneous coronary intervention as assessed by invasive bolus thermodilution.
Time frame: 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).
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).
Time frame: From enrollment until hospital discharge (up to 7 days from enrollment)
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).
Time frame: 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.
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.
Time frame: 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.
To correlate the burden of micro- and nanoplastics (MNPs) in coronary thromboaspirate with the in-hospital arrhythmic burden.
Time frame: 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.
To correlate the burden of micro- and nanoplastics (MNPs) in coronary thromboaspirate with in-hospital cardiovascular death.
Time frame: 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.
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.
Time frame: From enrollment to 3-month follow-up.
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.
Time frame: 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.
To correlate the burden of micro- and nanoplastics (MNPs) in coronary thromboaspirate with all-cause death at 1-year follow-up.
Time frame: From enrollment to 1 year follow-up.
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.
Time frame: 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.
To correlate the burden of micro- and nanoplastics (MNPs) in coronary thromboaspirate with hospitalization for heart failure at 1-year follow-up.
Time frame: 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.
To correlate the burden of micro- and nanoplastics (MNPs) in coronary thromboaspirate with the recurrence of myocardial infarction at 1-year follow-up.
Time frame: 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.
To correlate the burden of micro- and nanoplastics (MNPs) in coronary thromboaspirate with target vessel failure at 1-year follow-up.
Time frame: 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.
To correlate the burden of micro- and nanoplastics (MNPs) in coronary thromboaspirate with major adverse cardiovascular events (MACE) at 1-year follow-up.
Time frame: From enrollment to 1 year follow-up.
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ST Elevation Myocardial Infarction →
Azienda Ospedaliera "Sant'Andrea"