Trials / Recruiting

RecruitingNCT07291609

Microplastics and Nanoplastics in Patients With Chronic Coronary Syndromes

Status: Recruiting
Phase: —
Study type: Observational
Enrollment: 120 (estimated)

Sponsor: Azienda Ospedaliera "Sant'Andrea" · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

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.

Conditions

Timeline

Start date: 2025-09-01
Primary completion: 2026-12-31
Completion: 2029-12-31
First posted: 2025-12-18
Last updated: 2025-12-18

Locations

6 sites across 1 country: Italy

Source: ClinicalTrials.gov record NCT07291609. Inclusion in this directory is not an endorsement.