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| Name | Class |
|---|---|
| University of Campania Luigi Vanvitelli | OTHER |
| Azienda Ospedaliera Universitaria Integrata Verona | OTHER |
| Morgagni Pierantoni Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | From enrollment until the date of hospital discharge, assessed up to 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). |
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Inclusion Criteria:
All the following inclusion criteria should be fulfilled:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emanuele Barbato, MD, PhD | Contact | +39 0633776115 | +39 0633776115 | emanuele.barbato@uniroma1.it |
| Clinical Research Unit Cardiology Dept. Sant'Andrea University Hospital | Contact | +39 0633778763 | cru.cardiologia@uniroma1.it |
| Name | Affiliation | Role |
|---|---|---|
| Pasquale Paolisso, MD, PhD | Sant'Andrea University Hospital | Study Chair |
| Marta Belmonte, MD | Sant'Andrea University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sant'Andrea University Hospital | Recruiting | Roma | Rome | 00189 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38428296 | Background | Liu S, Wang C, Yang Y, Du Z, Li L, Zhang M, Ni S, Yue Z, Yang K, Wang Y, Li X, Yang Y, Qin Y, Li J, Yang Y, Zhang M. Microplastics in three types of human arteries detected by pyrolysis-gas chromatography/mass spectrometry (Py-GC/MS). J Hazard Mater. 2024 May 5;469:133855. doi: 10.1016/j.jhazmat.2024.133855. Epub 2024 Feb 21. | |
| 38614011 |
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| Azienda Ospedaliera Sant'Anna e San Sebastiano |
| OTHER |
| University Hospital, Catania | OTHER |
| A.O.U. Città della Salute e della Scienza - Molinette Hospital | OTHER |
| Niguarda Hospital | OTHER |
| Azienda Ospedaliera Universitaria Ferrara | UNKNOWN |
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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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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. | 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. |
| Department of Environmental Biological and Pharmaceutical Sciences and Technologies, University of Campania "Luigi Vanvitelli | Active, not recruiting | Caserta | Italy |
| Division of Cardiology, A.O.R.N. "Sant'Anna e San Sebastiano", Caserta, Italy. | Not yet recruiting | Caserta | Italy |
|
| Cardiovascular Department, A.O.U. Policlinico "G. Rodolico - San Marco", University of Catania, Catania, Italy. | Not yet recruiting | Catania | Italy |
|
| Azienda Ospedaliero Universitaria di Ferrara, Cona, Italy | Not yet recruiting | Ferrara | Italy |
|
| Cardiovascular Division, Morgagni-Pierantoni University Hospital, Forlì, Italy. | Not yet recruiting | Forlì | Italy |
|
| Interventional Cardiology Unit, De Gasperis Cardio Center, Niguarda Hospital, Milan, Italy. | Not yet recruiting | Milan | Italy |
|
| Department of Advanced Medical and Surgical Sciences, University of Campania-Luigi Vanvitelli, Naples, Italy. | Active, not recruiting | Naples | Italy |
| Division of Cardiology, Cardiovascular and Thoracic Department, Città della Salute e della Scienza, Turin, Italy. | Not yet recruiting | Turin | Italy |
|
| Azienda Ospedaliera Integrata Verona, Italy | Recruiting | Verona | Italy |
|
| Wang T, Yi Z, Liu X, Cai Y, Huang X, Fang J, Shen R, Lu W, Xiao Y, Zhuang W, Guo S. Multimodal detection and analysis of microplastics in human thrombi from multiple anatomically distinct sites. EBioMedicine. 2024 May;103:105118. doi: 10.1016/j.ebiom.2024.105118. Epub 2024 Apr 13. |
| 39283932 | Background | Lee DH. Microplastics and Cardiovascular Diseases: Importance of Coexisting Environmental Pollutants. Circulation. 2024 Sep 17;150(12):908-910. doi: 10.1161/CIRCULATIONAHA.124.069801. Epub 2024 Sep 16. No abstract available. |
| 39164741 | Background | Yang Y, Zhang F, Jiang Z, Du Z, Liu S, Zhang M, Jin Y, Qin Y, Yang X, Wang C, Gao H. Microplastics are associated with elevated atherosclerotic risk and increased vascular complexity in acute coronary syndrome patients. Part Fibre Toxicol. 2024 Aug 21;21(1):34. doi: 10.1186/s12989-024-00596-4. |
| 36473237 | Background | Zhu X, Wang C, Duan X, Liang B, Genbo Xu E, Huang Z. Micro- and nanoplastics: A new cardiovascular risk factor? Environ Int. 2023 Jan;171:107662. doi: 10.1016/j.envint.2022.107662. Epub 2022 Nov 26. |
| 39240674 | Background | Prattichizzo F, Ceriello A, Pellegrini V, La Grotta R, Graciotti L, Olivieri F, Paolisso P, D'Agostino B, Iovino P, Balestrieri ML, Rajagopalan S, Landrigan PJ, Marfella R, Paolisso G. Micro-nanoplastics and cardiovascular diseases: evidence and perspectives. Eur Heart J. 2024 Oct 7;45(38):4099-4110. doi: 10.1093/eurheartj/ehae552. |
| 38446676 | Background | Marfella R, Prattichizzo F, Sardu C, Fulgenzi G, Graciotti L, Spadoni T, D'Onofrio N, Scisciola L, La Grotta R, Frige C, Pellegrini V, Municino M, Siniscalchi M, Spinetti F, Vigliotti G, Vecchione C, Carrizzo A, Accarino G, Squillante A, Spaziano G, Mirra D, Esposito R, Altieri S, Falco G, Fenti A, Galoppo S, Canzano S, Sasso FC, Matacchione G, Olivieri F, Ferraraccio F, Panarese I, Paolisso P, Barbato E, Lubritto C, Balestrieri ML, Mauro C, Caballero AE, Rajagopalan S, Ceriello A, D'Agostino B, Iovino P, Paolisso G. Microplastics and Nanoplastics in Atheromas and Cardiovascular Events. N Engl J Med. 2024 Mar 7;390(10):900-910. doi: 10.1056/NEJMoa2309822. |
| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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