Actively Recruiting
Microplastics and Nanoplastics in Patients With Chronic Coronary Syndromes
Led by Azienda Ospedaliera "Sant'Andrea" · Updated on 2025-12-18
120
Participants Needed
6
Research Sites
226 weeks
Total Duration
On this page
Sponsors
A
Azienda Ospedaliera "Sant'Andrea"
Lead Sponsor
U
University of Campania Luigi Vanvitelli
Collaborating Sponsor
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Microplastics and Nanoplastics in Patients With Chronic Coronary Syndromes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age > 18 years old
- Suspected or known chronic coronary syndromes undergoing coronary CT angiography
- Clinical indication to invasive coronary angiography
- Able to give informed consent
You will not qualify if you...
- Coronary CT angiography not available
- Poor quality coronary CT angiography
- No native coronary stenosis ≥50% at coronary CT angiography
- Contraindications to invasive coronary angiography and percutaneous coronary intervention
- Life expectancy less than 1 year due to non-cardiac conditions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Division of Cardiology, A.O.R.N. "Sant'Anna e San Sebastiano", Caserta, Italy.
Caserta, Italy
Not Yet Recruiting
2
Cardiovascular Division, Morgagni-Pierantoni University Hospital, Forlì, Italy.
Forlì, Italy
Not Yet Recruiting
3
Centro Cardiologico Monzino
Milan, Italy
Active, Not Recruiting
4
Department of Advanced Medical and Surgical Sciences, University of Campania-Luigi Vanvitelli, Naples, Italy.
Naples, Italy
Active, Not Recruiting
5
Sant'Andrea University Hospital
Roma, Italy
Actively Recruiting
6
Azienda Ospedaliera Integrata Verona, Italy
Verona, Italy
Actively Recruiting
Research Team
E
Emanuele Barbato, MD, PhD
CONTACT
C
Clinical Research Unit Cardiology Dept. Sant'Andrea University Hospital
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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