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Microplastics and Nanoplastics in Patients With Chronic Coronary Syndromes

Status: Recruiting
Location: See all (6) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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.

Locations
Other Locations
Italy
Division of Cardiology, A.O.R.N. Sant'Anna e San Sebastiano, Caserta, Italy.
NOT_YET_RECRUITING
Caserta
Cardiovascular Division, Morgagni-Pierantoni University Hospital, Forlì, Italy.
NOT_YET_RECRUITING
Forlì
Centro Cardiologico Monzino
ACTIVE_NOT_RECRUITING
Milan
Department of Advanced Medical and Surgical Sciences, University of Campania-Luigi Vanvitelli, Naples, Italy.
ACTIVE_NOT_RECRUITING
Naples
Sant'Andrea University Hospital
RECRUITING
Roma
Azienda Ospedaliera Integrata Verona, Italy
RECRUITING
Verona
Contact Information
Primary
Emanuele Barbato, MD, PhD
emanuele.barbato@uniroma1.it
+39 0633776115
Backup
Clinical Research Unit Cardiology Dept. Sant'Andrea University Hospital
cru.cardiologia@uniroma1.it
+39 0633778763
Time Frame
Start Date: 2025-09-01
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 120
Treatments
CCS patients with presence of micro- and nano-plastics (MNPs+)
Consecutive patients undergoing coronary CT angiography (CCTA) for suspected or known chronic coronary syndromes (CCS) referred to invasive coronary angiography for clinical indication with the presence of micro- and nano-plastics (MNPs +).
CCS patients without the presence of micro- and nano-plastics (MNPs-)
Consecutive patients undergoing coronary CT angiography (CCTA) for suspected or known chronic coronary syndromes (CCS) referred to invasive coronary angiography for clinical indication without the presence of micro- and nano-plastics (MNPs -).
Related Therapeutic Areas
Sponsors
Collaborators: Azienda Ospedaliera Universitaria Integrata Verona, Centro Cardiologico Monzino, Milan, Italy, University of Campania Luigi Vanvitelli, Azienda Ospedaliera Sant'Anna e San Sebastiano, Morgagni Pierantoni Hospital
Leads: Azienda Ospedaliera Sant'Andrea

This content was sourced from clinicaltrials.gov