Microplastics and Nanoplastics in Patients With Chronic Coronary Syndromes

NCT07291609 | Recruiting

• 1 other identifier: 1000/2025
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 6

Brief Summary

The CCS-plastics is an investigator-initiated, prospective, multicenter study of patients undergoing coronary CT angiography (CCTA) for suspected or known chronic coronary syndromes (CCS) referred to invasive coronary angiography for clinical indication. Patients identified as eligible for the protocol will be asked for written consent to participate in the study. The patients' dossiers will be uploaded and transmitted to the core laboratory for analysis. The routine management of the CCS patients will not be affected and all patients will be managed according to current standards. Invasive coronary angiography and coronary blood samples will be performed following the current standards, guidelines, and indications. During invasive coronary angiography, coronary blood samples will be collected per standard of care and sent to a centralized, specialized core laboratory for MNPs and biomarkers analysis. The central core lab for MNPs analyses will be the University of Campania Luigi Vanvitelli, Naples, Italy. The identification, quantification (concentration, mcg/ml), and typing of plastic particles will be performed in each tube for each patient, using pyrolysis-gas chromatography-mass spectrometry (Py-GC/MS) and laser direct infrared (LDIR) spectroscopy. The CCTA will be centrally analyzed by Centro Cardiologico Monzino to evaluate qualitative and quantitative plaque features. Patients will be followed clinically at 1 and 3 years per standard of care.

Conditions

Chronic Coronary Syndrome; Microplastics; Nanoplastics; Coronary Artery Disease; Coronary Plaque; Computed Tomography; Pollution Exposure

Outcome Measures

Primary Outcomes (2)

• Burden of micro- and nanoplastics (MNPs) in the coronary blood of patients with chronic coronary syndromes (CCS) and obstructive coronary artery disease (CAD)

  To measure the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in the coronary blood of patients with chronic coronary syndromes (CCS) and obstructive CAD (diameter stenosis\>50%)

  From enrollment until the date of hospital discharge, assessed up to 7 days

• Burden of micro- and nanoplastics (MNPs) in the coronary blood of patients with chronic coronary syndromes (CCS) and plaque features at coronary computed tomography angiography.

  Correlation of the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in the coronary blood of patients with chronic coronary syndromes (CCS) with quantitative and qualitative plaque features at coronary computed tomography angiography.

  From enrollment until the date of hospital discharge, assessed up to 7 days

Secondary Outcomes (21)

• Correlation of the burden of micro- and nanoplastics (MNPs) in the coronary blood of patients with chronic coronary syndromes (CCS) with diameter stenosis at coronary computed tomography angiography (CCTA).

  From enrollment until the date of hospital discharge, assessed up to 7 days.

• Correlation of the burden of micro- and nanoplastics (MNPs) in the coronary blood of patients with chronic coronary syndromes (CCS) with plaque burden at coronary computed tomography angiography (CCTA).

  From enrollment until the date of hospital discharge, assessed up to 7 days

• Correlation of the burden of micro- and nanoplastics (MNPs) in the coronary blood of patients with chronic coronary syndromes (CCS) with plaque morphology at coronary computed tomography angiography (CCTA).

  From enrollment until the date of hospital discharge, assessed up to 7 days

• Correlation of the burden of micro- and nanoplastics (MNPs) in the coronary blood of patients with chronic coronary syndromes (CCS) with the presence of high-risk plaque features at coronary computed tomography angiography (CCTA).

  From enrollment until the date of hospital discharge, assessed up to 7 days

• Correlation of the burden of micro- and nanoplastics (MNPs) in the coronary blood of patients with chronic coronary syndromes (CCS) with the presence and burden of calcium at coronary computed tomography angiography (CCTA).

  From enrollment until the date of hospital discharge, assessed up to 7 days.

Study Arms (2)

CCS patients with presence of micro- and nano-plastics (MNPs+)

Consecutive patients undergoing coronary CT angiography (CCTA) for suspected or known chronic coronary syndromes (CCS) referred to invasive coronary angiography for clinical indication with the presence of micro- and nano-plastics (MNPs +).

CCS patients without the presence of micro- and nano-plastics (MNPs-)

Consecutive patients undergoing coronary CT angiography (CCTA) for suspected or known chronic coronary syndromes (CCS) referred to invasive coronary angiography for clinical indication without the presence of micro- and nano-plastics (MNPs -).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consecutive patients undergoing coronary CT angiography (CCTA) for suspected or known chronic coronary syndromes (CCS) referred to invasive coronary angiography for clinical indication.

You may qualify if:

• ALL the following:
• Age \> 18 years old;
• Suspected or known chronic coronary syndromes undergoing coronary CT angiography;
• Clinical indication to invasive coronary angiography;
• Able to give informed consent.

You may not qualify if:

• Coronary CT angiography not available;
• Poor quality CCTA;
• Absence of native coronary stenosis \>=50% at CCTA;
• Contraindications to invasive coronary angiography and percutaneous coronary intervention
• Life expectancy \< 1 year due to non-cardiac pathology

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: collaborator
• Azienda Ospedaliera Universitaria Integrata Verona: collaborator
• Morgagni Pierantoni Hospital: collaborator
• Azienda Ospedaliera Sant'Anna e San Sebastiano: collaborator
• Centro Cardiologico Monzino, Milan, Italy: collaborator
• Azienda Ospedaliera "Sant'Andrea": lead

Study Sites (6)

Division of Cardiology, A.O.R.N. "Sant'Anna e San Sebastiano", Caserta, Italy.

Caserta, Italy

NOT YET RECRUITING

Cardiovascular Division, Morgagni-Pierantoni University Hospital, Forlì, Italy.

Forlì, Italy

NOT YET RECRUITING

Centro Cardiologico Monzino

Milan, Italy

ACTIVE NOT RECRUITING

Department of Advanced Medical and Surgical Sciences, University of Campania-Luigi Vanvitelli, Naples, Italy.

Naples, Italy

ACTIVE NOT RECRUITING

Sant'Andrea University Hospital

Roma, Italy

RECRUITING

Azienda Ospedaliera Integrata Verona, Italy

Verona, Italy

RECRUITING

Related Publications (5)

• 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.

  PMID: 39283932 BACKGROUND

• 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.

  PMID: 38614011 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.

  PMID: 38446676 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.

  PMID: 39240674 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.

  PMID: 38428296 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Emanuele Barbato, MD, PhD

CONTACT

+39 0633776115; emanuele.barbato@uniroma1.it

Clinical Research Unit Cardiology Dept. Sant'Andrea University Hospital

CONTACT

+39 0633778763; cru.cardiologia@uniroma1.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 18, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2029
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (6)