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Microplastics and Nanoplastics in Patients With Chronic Coronary Syndromes

NCT ID: NCT07291609

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-01

Study Completion Date

2029-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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 +).

No interventions assigned to this group

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 -).

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

ALL the following:

1. Age \> 18 years old;
2. Suspected or known chronic coronary syndromes undergoing coronary CT angiography;
3. Clinical indication to invasive coronary angiography;
4. Able to give informed consent.

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Campania Luigi Vanvitelli

OTHER

Sponsor Role collaborator

Azienda Ospedaliera Universitaria Integrata Verona

OTHER

Sponsor Role collaborator

Morgagni Pierantoni Hospital

OTHER

Sponsor Role collaborator

Azienda Ospedaliera Sant'Anna e San Sebastiano

OTHER

Sponsor Role collaborator

Centro Cardiologico Monzino, Milan, Italy

UNKNOWN

Sponsor Role collaborator

Azienda Ospedaliera "Sant'Andrea"

OTHER

Sponsor Role lead

Responsible Party

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Emanuele Barbato

Full Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Caserta, , Italy

Site Status NOT_YET_RECRUITING

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

Forlì, , Italy

Site Status NOT_YET_RECRUITING

Centro Cardiologico Monzino

Milan, , Italy

Site Status ACTIVE_NOT_RECRUITING

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

Napoli, , Italy

Site Status ACTIVE_NOT_RECRUITING

Sant'Andrea University Hospital

Roma, , Italy

Site Status RECRUITING

Azienda Ospedaliera Integrata Verona, Italy

Verona, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Emanuele Barbato, MD, PhD

Role: CONTACT

Phone: +39 0633776115

Email: [email protected]

Clinical Research Unit Cardiology Dept. Sant'Andrea University Hospital

Role: CONTACT

Phone: +39 0633778763

Email: [email protected]

Facility Contacts

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Paolo Calabrò, MD, Phd

Role: primary

Carmine Pizzi, MD, Phd

Role: primary

Emanuele Barbato, MD, Phd

Role: primary

Clinical Research Unit

Role: backup

Flavio Ribichini, MD, Phd

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 39283932 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38614011 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38446676 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39240674 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38428296 (View on PubMed)

Other Identifiers

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1000/2025

Identifier Type: -

Identifier Source: org_study_id