Actively Recruiting

Age: 18Years +
All Genders
NCT07291609

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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Microplastics and Nanoplastics in Patients With Chronic Coronary Syndromes | DecenTrialz