Microplastics and Nanoplastics (MNPs) in Patients With ST-elevation Myocardial Infarction (STEMI)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAzienda Ospedaliera "Sant'Andrea"
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age > 18 years old;
STEMI undergoing urgent invasive coronary angiography;
Acute thrombotic coronary occlusion/sub-occlusion (TIMI 0/1);
Clinical indication to thromboaspiration;
Disqualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
130 Participants
are grouped into 2 trial groupsGroup A: STEMI patients with presence of micro- and nano-plastics (MNPs).
Group B: STEMI patients without presence of micro- and nano-plastics (MNPs)
Trial outcomes
Primary outcomes
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.
Time frame
From enrollment until the date of hospital discharge, assessed up to 7 days2
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 daysSecondary outcomes
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.
Time frame
From enrollment until the date of hospital discharge, assessed up to 7 days2
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)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.
Time frame
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.
Time frame
From enrollment until hospital discharge (up to 7 days from enrollment)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Azienda Ospedaliera "Sant'Andrea"
Lead sponsor
University of Campania Luigi Vanvitelli
Collaborator
Azienda Ospedaliera Universitaria Integrata Verona
Collaborator
Morgagni Pierantoni Hospital
Collaborator
Azienda Ospedaliera Sant'Anna e San Sebastiano
Collaborator
University Hospital, Catania
Collaborator
A.O.U. Città della Salute e della Scienza - Molinette Hospital
Collaborator
Niguarda Hospital
Collaborator
Azienda Ospedaliera Universitaria Ferrara
Collaborator
Source ClinicalTrials.gov