NCT Number: NCT07291609
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Division of Cardiology, A.O.R.N. "Sant'Anna e San Sebastiano", Caserta, Italy., Caserta, Italy
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
ALL the following:
Exclusion criteria
Time frame: From enrollment until the date of hospital discharge, assessed up to 7 days
To measure the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in the coronary blood of patients with chronic coronary syndromes (CCS) and obstructive CAD (diameter stenosis>50%)
Time frame: From enrollment until the date of hospital discharge, assessed up to 7 days
Correlation of the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in the coronary blood of patients with chronic coronary syndromes (CCS) with quantitative and qualitative plaque features at coronary computed tomography angiography.
Time frame: From enrollment until the date of hospital discharge, assessed up to 7 days.
To correlate the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in the coronary blood of patients with chronic coronary syndromes (CCS) with the diameter stenosis at coronary computed tomography angiography (CCTA).
Time frame: From enrollment until the date of hospital discharge, assessed up to 7 days
To correlate the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in the coronary blood of patients with chronic coronary syndromes (CCS) with plaque burden at coronary computed tomography angiography (CCTA).
Time frame: From enrollment until the date of hospital discharge, assessed up to 7 days
To correlate the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in the coronary blood of patients with chronic coronary syndromes (CCS) with plaque morphology at coronary computed tomography angiography (CCTA).
Time frame: From enrollment until the date of hospital discharge, assessed up to 7 days
To correlate the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in the coronary blood of patients with chronic coronary syndromes (CCS) with the presence of high-risk plaque features at coronary computed tomography angiography (CCTA).
Time frame: From enrollment until the date of hospital discharge, assessed up to 7 days.
To correlate the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in the coronary blood of patients with chronic coronary syndromes (CCS) with the presence and burden of calcium at coronary computed tomography angiography (CCTA).
Time frame: From enrollment until the date of hospital discharge, assessed up to 7 days
To correlate the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in the coronary blood of patients with chronic coronary syndromes (CCS) with the pericoronary fat attenuation index at coronary computed tomography angiography (CCTA).
Time frame: From enrollment until the date of hospital discharge, assessed up to 7 days
To correlate the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with vessel-specific ischemia.
Time frame: From enrollment until the date of hospital discharge, assessed up to 7 days
To correlate the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with platelet reactivity as assessed by aggregometry.
Time frame: From enrollment until the date of hospital discharge, assessed up to 7 days
To correlate the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with the occurrence of periprocedural events.
Time frame: From enrollment to 1-year follow-up.
To correlate the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with major adverse cardiovascular events (cardiovascular death, myocardial infarction, any revascularization, hospitalization for heart failure) at 1-year follow-up.
Time frame: From enrollment to 1-year follow-up.
To correlate the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with all-cause death at 1-year follow-up.
Time frame: From enrollment to 1-year follow-up.
To correlate the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with cardiovascular death at 1-year follow-up.
Time frame: From enrollment to 1-year follow-up.
To correlate the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with myocardial infarction at 1-year follow-up.
Time frame: From enrollment to 1-year follow-up.
To correlate the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with any revascularization at 1-year follow-up.
Time frame: From enrollment to 1-year follow-up.
To correlate the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with hospitalization for heart failure at 1-year follow-up.
Time frame: From enrollment to 3-year follow-up.
To correlate the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with major adverse cardiovascular events (cardiovascular death, myocardial infarction, any revascularization, hospitalization for heart failure) at 3-year follow-up.
Time frame: From enrollment to 3-year follow-up.
To correlate the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with all-cause death at 3-year follow-up.
Time frame: From enrollment to 3-year follow-up.
To correlate the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with cardiovascular death at 3-year follow-up.
Time frame: From enrollment to 3-year follow-up.
To correlate the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with myocardial infarction at 3-year follow-up.
Time frame: From enrollment to 3-year follow-up.
To correlate the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with any revascularization at 3-year follow-up.
Time frame: From enrollment to 3-year follow-up.
To correlate the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with hospitalization for heart failure at 3-year follow-up
Contact information is provided by the study sponsor or research team.
Clinical Research Unit Cardiology Dept. Sant'Andrea University Hospital
CONTACT
Emanuele Barbato, MD, PhD
CONTACT
Azienda Ospedaliera "Sant'Andrea"
Other
Acronym: CCS-Plastics
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07329699
Acute Coronary Syndrome, Arterial Occlusive Diseases
Seoul, Select State, South Korea
View Trial DetailsNCT05865600
Angina Pectoris, Angina, Stable
Herning, Central Jutland, Denmark
View Trial DetailsNCT06185530
Arterial Occlusive Diseases, Arteriosclerosis
Harrow, Middx, United Kingdom
View Trial DetailsNCT06578234
Arterial Occlusive Diseases, Arteriosclerosis
Lund, Sweden
View Trial Details