Microplastics, Nanoplastics, Pollution Exposure, ST-elevation Myocardial Infarction (STEMI)
Conditions
Keywords
STEMI, Microplastics, Nanoplastics, Inflammation, OCT, Plaque composition, cardiac magnetic resonance, Pollution, Exposome, Infarct Size, Coronary Microvascular Dysfunction, IMR, MRR
Brief 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. 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.
Interventions
None listed
Sponsors
University of Campania Luigi Vanvitelli
Azienda Ospedaliera Universitaria Integrata Verona
Morgagni Pierantoni Hospital
Azienda Ospedaliera Sant'Anna e San Sebastiano
University Hospital, Catania
A.O.U. Città della Salute e della Scienza - Molinette Hospital
Niguarda Hospital
Azienda Ospedaliera Universitaria Ferrara
Azienda Ospedaliera Sant'Andrea
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Burden of micro- and nanoplastics (MNPs) in coronary thromboaspirate in STEMI patients. | 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. |
| Correlation of micro- and nanoplastics (MNPs) in coronary thromboaspirate in STEMI patients with inflammatory and cardiac damage biomarkers. | 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
| Measure | Time frame | Description |
|---|---|---|
| Burden of micro- and nanoplastics (MNPs) in STEMI patients across different geographic regions. | 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. |
| Association of burden of micro- and nanoplastics (MNPs) with air pollution. | 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. |
| Differences in the burden of micro- and nanoplastics (MNPs) across biological samples. | 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. |
| Micro- and nanoplastics (MNPs) in diabetic vs. non-diabetic patients. | 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. |
| Micro- and nanoplastics (MNPs) in patients with and without chronic kidney disease. | 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. |
| Micro- and nanoplastics (MNPs) clearance in patients with and without chronic kidney disease. | 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. |
| Variation in the burden of micro- and nanoplastics (MNPs) between baseline and follow-up. | 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. |
| Association of the burden of micro- and nanoplastics (MNPs) with coronary reperfusion. | 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. |
| Association of the burden of micro- and nanoplastics (MNPs) with plaque composition as assessed by optical coherence tomography (OCT). | 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). |
| Association of the burden of micro- and nanoplastics (MNPs) with microvascular dysfunction/obstruction post PCI as assessed by invasive bolus thermodilution. | 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. |
| 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). | 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). |
| Burden of micro- and nanoplastics (MNPs) in culprit vs. non-culprit vessels. | 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. |
| Association of the burden of micro- and nanoplastics (MNPs) with left ventricular ejection fraction and wall motion score index at echocardiography. | 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. |
| Association of the burden of micro- and nanoplastics (MNPs) with in-hospital arrhythmic burden. | 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. |
| Association of the burden of micro- and nanoplastics (MNPs) with in-hospital cardiovascular death. | 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. |
| Association of the burden of micro- and nanoplastics (MNPs) with left ventricular recovery at 3 months follow-up. | 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. |
| Association of the burden of micro- and nanoplastics (MNPs) with recurrence angina at 3-month follow-up. | 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. |
| Association of the burden of micro- and nanoplastics (MNPs) with all-cause death at 1-year follow-up. | 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. |
| Association of the burden of micro- and nanoplastics (MNPs) with cardiovascular death at 1-year follow-up. | 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. |
| Association of the burden of micro- and nanoplastics (MNPs) with hospitalization for heart failure at 1-year follow-up. | 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. |
| Association of the burden of micro- and nanoplastics (MNPs) with the recurrence of myocardial infarction at 1-year follow-up. | 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. |
| Association of the burden of micro- and nanoplastics (MNPs) with target vessel failure at 1-year follow-up. | 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. |
| Association of the burden of micro- and nanoplastics (MNPs) with major adverse cardiovascular events (MACE) at 1-year follow-up. | 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. |
| Association of the burden of micro- and nanoplastics (MNPs) with peak Troponin. | 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). |
| Age- and sex- related differences in the burden of micro- and nanoplastics (MNPs). | 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. |
Countries
Italy
Contacts
Primary ContactEmanuele Barbato, MD, PhD
Backup ContactClinical Research Unit Cardiology Dept. Sant'Andrea University Hospital
Outcome results
None listed