Microplastics and Nanoplastics in Patients With Chronic Coronary Syndromes

NCT07291609 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2025-12-18

No results posted yet for this study

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

Sponsors & Collaborators

  • University of Campania Luigi Vanvitelli

    collaborator OTHER
  • Azienda Ospedaliera Universitaria Integrata Verona

    collaborator OTHER
  • Morgagni Pierantoni Hospital

    collaborator OTHER
  • Azienda Ospedaliera Sant'Anna e San Sebastiano

    collaborator OTHER
  • Centro Cardiologico Monzino, Milan, Italy

    collaborator UNKNOWN
  • Azienda Ospedaliera "Sant'Andrea"

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2026-12-31
Completion
2029-12-31

Countries

  • Italy

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07291609 on ClinicalTrials.gov