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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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Sant'Andrea University Hospital
Roma, Italy
Azienda Ospedaliera Integrata Verona, Italy
Verona, Italy
Start Date
September 1, 2025
Primary Completion Date
December 31, 2026
Completion Date
December 31, 2029
Last Updated
December 18, 2025
120
ESTIMATED participants
Clinical Research Unit Cardiology Dept. Sant'Andrea University Hospital
CONTACT
+39 0633778763cru.cardiologia@uniroma1.itLead Sponsor
Azienda Ospedaliera "Sant'Andrea"
Collaborators
NCT07195149
NCT05865600
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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