Microplastics and Nanoplastics in Patients With Chronic Coronary Syndromes (CCS-Plastics)

Sant'Andrea University Hospital

Status: Enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT07291609

1000/2025

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

ALL the following:

1. Age > 18 years old;
2. Suspected or known chronic coronary syndromes undergoing coronary CT angiography;
3. Clinical indication to invasive coronary angiography;
4. Able to give informed consent.

Exclusion criteria

1. Coronary CT angiography not available;
2. Poor quality CCTA;
3. Absence of native coronary stenosis >=50% at CCTA;
4. Contraindications to invasive coronary angiography and percutaneous coronary intervention
5. Life expectancy < 1 year due to non-cardiac pathology

Trial design

120 participants in 2 patient groups

CCS patients with presence of micro- and nano-plastics (MNPs+)

Description:

Consecutive patients undergoing coronary CT angiography (CCTA) for suspected or known chronic coronary syndromes (CCS) referred to invasive coronary angiography for clinical indication with the presence of micro- and nano-plastics (MNPs +).

CCS patients without the presence of micro- and nano-plastics (MNPs-)

Description:

Consecutive patients undergoing coronary CT angiography (CCTA) for suspected or known chronic coronary syndromes (CCS) referred to invasive coronary angiography for clinical indication without the presence of micro- and nano-plastics (MNPs -).