Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07291609

Microplastics and Nanoplastics in Patients With Chronic Coronary Syndromes

Sponsor: Azienda Ospedaliera "Sant'Andrea"

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

120

Start Date

2025-09-01

Completion Date

2029-12-31

Last Updated

2025-12-18

Healthy Volunteers

No

Locations (6)

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