Microplastics and Nanoplastics in Patients With Chronic Coronary Syndromes
Key facts
- Where
- Caserta, Forlì, Milan, Naples, Roma, and Verona, ItalySee the 6 sites
Where in Italy
- Division of Cardiology, A.O.R.N. "Sant'Anna e San Sebastiano", Caserta, Italy.Caserta, ItalyNot yet recruiting
- Cardiovascular Division, Morgagni-Pierantoni University Hospital, Forlì, Italy.Forlì, ItalyNot yet recruiting
- Centro Cardiologico MonzinoMilan, ItalyNo longer taking part
- Department of Advanced Medical and Surgical Sciences, University of Campania-Luigi Vanvitelli, Naples, Italy.Naples, ItalyNo longer taking part
- Sant'Andrea University HospitalRoma, ItalyTaking people
- Azienda Ospedaliera Integrata Verona, ItalyVerona, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Azienda Ospedaliera "Sant'Andrea"
- Trial code
- NCT07291609
- Record updated
- 9 June 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: Life expectancy < 1 year due to non-cardiac pathology; 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.