Microplastics and Nanoplastics in Patients With Chronic Coronary Syndromes

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAzienda Ospedaliera "Sant'Andrea"

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial population

Consecutive patients undergoing coronary CT angiography (CCTA) for suspected or known chronic coronary syndromes (CCS) referred to invasive coronary angiography for clinical indication.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

120 Participants
are grouped into 2 trial groups
Group A: CCS patients with presence of micro- and nano-plastics (MNPs+)
Group B: CCS patients without the presence of micro- and nano-plastics (MNPs-)

Trial outcomes

Primary outcomes

1

Burden of micro- and nanoplastics (MNPs) in the coronary blood of patients with chronic coronary syndromes (CCS) and obstructive coronary artery disease (CAD)

To measure the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in the coronary blood of patients with chronic coronary syndromes (CCS) and obstructive CAD (diameter stenosis\>50%)

Time frame
From enrollment until the date of hospital discharge, assessed up to 7 days
2

Burden of micro- and nanoplastics (MNPs) in the coronary blood of patients with chronic coronary syndromes (CCS) and plaque features at coronary computed tomography angiography.

Correlation of the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in the coronary blood of patients with chronic coronary syndromes (CCS) with quantitative and qualitative plaque features at coronary computed tomography angiography.

Time frame
From enrollment until the date of hospital discharge, assessed up to 7 days

Secondary outcomes

1

Correlation of the burden of micro- and nanoplastics (MNPs) in the coronary blood of patients with chronic coronary syndromes (CCS) with diameter stenosis at coronary computed tomography angiography (CCTA).

To correlate the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in the coronary blood of patients with chronic coronary syndromes (CCS) with the diameter stenosis at coronary computed tomography angiography (CCTA).

Time frame
From enrollment until the date of hospital discharge, assessed up to 7 days.
2

Correlation of the burden of micro- and nanoplastics (MNPs) in the coronary blood of patients with chronic coronary syndromes (CCS) with plaque burden at coronary computed tomography angiography (CCTA).

To correlate the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in the coronary blood of patients with chronic coronary syndromes (CCS) with plaque burden at coronary computed tomography angiography (CCTA).

Time frame
From enrollment until the date of hospital discharge, assessed up to 7 days
3

Correlation of the burden of micro- and nanoplastics (MNPs) in the coronary blood of patients with chronic coronary syndromes (CCS) with plaque morphology at coronary computed tomography angiography (CCTA).

To correlate the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in the coronary blood of patients with chronic coronary syndromes (CCS) with plaque morphology at coronary computed tomography angiography (CCTA).

Time frame
From enrollment until the date of hospital discharge, assessed up to 7 days
4

Correlation of the burden of micro- and nanoplastics (MNPs) in the coronary blood of patients with chronic coronary syndromes (CCS) with the presence of high-risk plaque features at coronary computed tomography angiography (CCTA).

To correlate the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in the coronary blood of patients with chronic coronary syndromes (CCS) with the presence of high-risk plaque features at coronary computed tomography angiography (CCTA).

Time frame
From enrollment until the date of hospital discharge, assessed up to 7 days

Other outcomes

Sponsors and contacts

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Azienda Ospedaliera "Sant'Andrea"

Lead sponsor

University of Campania Luigi Vanvitelli

Collaborator

Azienda Ospedaliera Universitaria Integrata Verona

Collaborator

Morgagni Pierantoni Hospital

Collaborator

Azienda Ospedaliera Sant'Anna e San Sebastiano

Collaborator

Centro Cardiologico Monzino, Milan, Italy

Collaborator