NCT07291609Recruiting
Microplastics and Nanoplastics in Patients With Chronic Coronary Syndromes
Source: ClinicalTrials.gov · Last updated 9 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 120 (estimated)
- First submitted
- 24 Nov 2025
- Start date
- Jan 2025
- Primary completion date
- Dec 2026
- Lead sponsor
- Azienda Ospedaliera "Sant'Andrea"
- Diseases
- Coronary artery disease
- NCT number
- NCT07291609
What you commit to
- Study type: Observational
- Planned participants: 120
- From Jan 2025 to the primary completion date, Dec 2026
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Life expectancy \< 1 year due to non-cardiac pathology
Other
- Coronary CT angiography not available;
- Poor quality CCTA;
- Absence of native coronary stenosis \>=50% at CCTA;
- Contraindications to invasive coronary angiography and percutaneous coronary intervention
Who the study is looking for
- ALL the following:
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Division of Cardiology, A.O.R.N. "Sant'Anna e San Sebastiano", Caserta, Italy. Coordinator of this site? Confirm its status | Caserta | Italy | Not yet recruiting |
| Cardiovascular Division, Morgagni-Pierantoni University Hospital, Forlì, Italy. Coordinator of this site? Confirm its status | Forlì | Italy | Not yet recruiting |
| Centro Cardiologico Monzino Coordinator of this site? Confirm its status | Milan | Italy | Active, not recruiting |
| Department of Advanced Medical and Surgical Sciences, University of Campania-Luigi Vanvitelli, Naples, Italy. Coordinator of this site? Confirm its status | Naples | Italy | Active, not recruiting |
| Sant'Andrea University Hospital Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
| Azienda Ospedaliera Integrata Verona, Italy Coordinator of this site? Confirm its status | Verona | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.