Microplastics and Nanoplastics in Patients With Chronic Coronary Syndromes

Recruiting now

Conditions studied: Chronic Coronary Syndrome, Microplastics, Nanoplastics, Coronary Artery Disease, Coronary Plaque, Computed Tomography, Pollution Exposure

In brief

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.

Key facts

Study ID

NCT07291609

Run by

Azienda Ospedaliera "Sant'Andrea"

People needed

120

Starts

2025-01-01

Expected to finish

2029-12-31

Last updated by the study team

2026-06-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Sant'Andrea University Hospital — Roma, Italy (enrolling)
• Azienda Ospedaliera Integrata Verona, Italy — Verona, Italy (enrolling)
• Division of Cardiology, A.O.R.N. "Sant'Anna e San Sebastiano", Caserta, Italy. — Caserta, Italy
• Cardiovascular Division, Morgagni-Pierantoni University Hospital, Forlì, Italy. — Forlì, Italy
• Centro Cardiologico Monzino — Milan, Italy
• Department of Advanced Medical and Surgical Sciences, University of Campania-Luigi Vanvitelli, Naples, Italy. — Naples, Italy

Full record on ClinicalTrials.gov

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