Chronic Coronary SyndromeCCS-PlasticsNCT07291609

Microplastics and Nanoplastics in Patients With Chronic Coronary Syndromes

An observational study of Chronic Coronary Syndrome and Microplastics, run by Azienda Ospedaliera "Sant'Andrea" at 6 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Coronary Syndrome, Microplastics, Nanoplastics
How many people: 120 participants
Where: 6 sitesItaly
Study dates: 1 Jan 2025to 31 Dec 2029
How long will I take part?: 3 Years
Phase: Observational
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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.

Who cannot join

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
Life expectancy < 1 year due to non-cardiac pathology

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Emanuele Barbato, MD, PhD contact

+39 0633776115

emanuele.barbato@uniroma1.it

Clinical Research Unit Cardiology Dept. Sant'Andrea University Hospital contact

+39 0633778763

cru.cardiologia@uniroma1.it

City, postcode or hospital

Sites recruiting now only

6 sites in 1 country

Italy6 sites, 4 recruiting

Division of Cardiology, A.O.R.N. "Sant'Anna e San Sebastiano", Caserta, Italy.
Caserta
Paolo Calabrò, MD, Phd, +3908231783012, paolo.calabro@unicampania.it
Felice Gragnano, MD, PhD
Not yet recruiting
Cardiovascular Division, Morgagni-Pierantoni University Hospital, Forlì, Italy.
Forlì
Carmine Pizzi, MD, Phd, +39 051 2144933, carmine.pizzi@unibo.it
Luca Bergamaschi, MD, PhD
Not yet recruiting
Centro Cardiologico Monzino
Milan
Active, not recruiting
Department of Advanced Medical and Surgical Sciences, University of Campania-Luigi Vanvitelli, Naples, Italy.
Naples
Active, not recruiting
Sant'Andrea University Hospital
Roma
Emanuele Barbato, MD, Phd, +390633776115, emanuele.barbato@uniroma1.it
Clinical Research Unit, +390633778763, cru.cardiologia@uniroma1.it
Recruiting
Azienda Ospedaliera Integrata Verona, Italy
Verona
Flavio Ribichini, MD, Phd, flavio.ribichini@univr.it
Roberto Scarsini, MD, PhD
Recruiting

Other trials in Italy

About this study

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: Chronic Coronary Syndrome, Microplastics, Nanoplastics, Coronary Artery Disease, Coronary Plaque, Computed Tomography
Medical subject headings: Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07291609
Study group	Role	What they receive
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 -).

What is being measured

The primary outcome is the main question the study is designed to answer.

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%)
Measured: From enrollment until the date of hospital discharge, assessed up to 7 days
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.
Measured: From enrollment until the date of hospital discharge, assessed up to 7 days

Secondary outcomes (21)

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).
Measured: From enrollment until the date of hospital discharge, assessed up to 7 days.
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).
Measured: From enrollment until the date of hospital discharge, assessed up to 7 days
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).
Measured: From enrollment until the date of hospital discharge, assessed up to 7 days
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).
Measured: From enrollment until the date of hospital discharge, assessed up to 7 days
Correlation of the burden of micro- and nanoplastics (MNPs) in the coronary blood of patients with chronic coronary syndromes (CCS) with the presence and burden of calcium 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 and burden of calcium at coronary computed tomography angiography (CCTA).
Measured: From enrollment until the date of hospital discharge, assessed up to 7 days.
Correlation of the burden of micro- and nanoplastics (MNPs) in the coronary blood of patients with chronic coronary syndromes (CCS) with the pericoronary fat attenuation index 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 pericoronary fat attenuation index at coronary computed tomography angiography (CCTA).
Measured: From enrollment until the date of hospital discharge, assessed up to 7 days
Correlation of the burden of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with vessel-specific ischemia.
To correlate the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with vessel-specific ischemia.
Measured: From enrollment until the date of hospital discharge, assessed up to 7 days
Correlation of the burden of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with platelet reactivity
To correlate the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with platelet reactivity as assessed by aggregometry.
Measured: From enrollment until the date of hospital discharge, assessed up to 7 days
Correlation of the burden of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with the occurrence of periprocedural events.
To correlate the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with the occurrence of periprocedural events.
Measured: From enrollment until the date of hospital discharge, assessed up to 7 days
Correlation of the burden of micro- and nanoplastics (MNPs) with major adverse cardiovascular events (cardiovascular death, myocardial infarction, any revascularization, hospitalization for heart failure) at 1-year follow-up.
To correlate the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with major adverse cardiovascular events (cardiovascular death, myocardial infarction, any revascularization, hospitalization for heart failure) at 1-year follow-up.
Measured: From enrollment to 1-year follow-up.
Correlation of the burden of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with all-cause death at 1-year follow-up.
To correlate the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with all-cause death at 1-year follow-up.
Measured: From enrollment to 1-year follow-up.
Correlation of the burden of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with cardiovascular death at 1-year follow-up.
To correlate the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with cardiovascular death at 1-year follow-up.
Measured: From enrollment to 1-year follow-up.
The correlation of the burden of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with myocardial infarction at 1-year follow-up.
To correlate the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with myocardial infarction at 1-year follow-up.
Measured: From enrollment to 1-year follow-up.
The correlation of the burden of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with any revascularization at 1-year follow-up.
To correlate the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with any revascularization at 1-year follow-up.
Measured: From enrollment to 1-year follow-up.
Correlation of the burden of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with hospitalization for heart failure at 1-year follow-up.
To correlate the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with hospitalization for heart failure at 1-year follow-up.
Measured: From enrollment to 1-year follow-up.
Correlation of the burden of micro- and nanoplastics (MNPs) with major adverse cardiovascular events (cardiovascular death, myocardial infarction, any revascularization, hospitalization for heart failure) at 3-year follow-up.
To correlate the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with major adverse cardiovascular events (cardiovascular death, myocardial infarction, any revascularization, hospitalization for heart failure) at 3-year follow-up.
Measured: From enrollment to 3-year follow-up.
Correlation of the burden of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with all-cause death at 3-year follow-up.
To correlate the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with all-cause death at 3-year follow-up.
Measured: From enrollment to 3-year follow-up.
Correlation of the burden of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with cardiovascular death at 3-year follow-up.
To correlate the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with cardiovascular death at 3-year follow-up.
Measured: From enrollment to 3-year follow-up.
Correlation of the burden of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with myocardial infarction at 3-year follow-up.
To correlate the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with myocardial infarction at 3-year follow-up.
Measured: From enrollment to 3-year follow-up.
Correlation of the burden of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with any revascularization at 3-year follow-up.
To correlate the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with any revascularization at 3-year follow-up.
Measured: From enrollment to 3-year follow-up.
Correlation of the burden of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with hospitalization for heart failure at 3-year follow-up
To correlate the burden (concentration, mcg/ml) of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with hospitalization for heart failure at 3-year follow-up
Measured: From enrollment to 3-year follow-up.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202531 Dec 2029

First posted18 Dec 2025
Study start1 Jan 2025
Primary completion31 Dec 2026 (estimated)
Study completion31 Dec 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Chronic Coronary SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 120 participants (estimated)
Target duration: 3 Years

IDs, dates and publications

ClinicalTrials.gov ID: NCT07291609
Sponsor's protocol ID: 1000/2025
Acronym: CCS-Plastics
Status last verified: Dec 2025
First submitted: 24 Nov 2025
Last updated: 9 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Lee DH. Microplastics and Cardiovascular Diseases: Importance of Coexisting Environmental Pollutants. Circulation. 2024 Sep 17;150(12):908-910. doi: 10.1161/CIRCULATIONAHA.124.069801. Epub 2024 Sep 16. No abstract available.
PubMed 39283932
Wang T, Yi Z, Liu X, Cai Y, Huang X, Fang J, Shen R, Lu W, Xiao Y, Zhuang W, Guo S. Multimodal detection and analysis of microplastics in human thrombi from multiple anatomically distinct sites. EBioMedicine. 2024 May;103:105118. doi: 10.1016/j.ebiom.2024.105118. Epub 2024 Apr 13.
PubMed 38614011
Marfella R, Prattichizzo F, Sardu C, Fulgenzi G, Graciotti L, Spadoni T, D'Onofrio N, Scisciola L, La Grotta R, Frige C, Pellegrini V, Municino M, Siniscalchi M, Spinetti F, Vigliotti G, Vecchione C, Carrizzo A, Accarino G, Squillante A, Spaziano G, Mirra D, Esposito R, Altieri S, Falco G, Fenti A, Galoppo S, Canzano S, Sasso FC, Matacchione G, Olivieri F, Ferraraccio F, Panarese I, Paolisso P, Barbato E, Lubritto C, Balestrieri ML, Mauro C, Caballero AE, Rajagopalan S, Ceriello A, D'Agostino B, Iovino P, Paolisso G. Microplastics and Nanoplastics in Atheromas and Cardiovascular Events. N Engl J Med. 2024 Mar 7;390(10):900-910. doi: 10.1056/NEJMoa2309822.
PubMed 38446676
Prattichizzo F, Ceriello A, Pellegrini V, La Grotta R, Graciotti L, Olivieri F, Paolisso P, D'Agostino B, Iovino P, Balestrieri ML, Rajagopalan S, Landrigan PJ, Marfella R, Paolisso G. Micro-nanoplastics and cardiovascular diseases: evidence and perspectives. Eur Heart J. 2024 Oct 7;45(38):4099-4110. doi: 10.1093/eurheartj/ehae552.
PubMed 39240674
Liu S, Wang C, Yang Y, Du Z, Li L, Zhang M, Ni S, Yue Z, Yang K, Wang Y, Li X, Yang Y, Qin Y, Li J, Yang Y, Zhang M. Microplastics in three types of human arteries detected by pyrolysis-gas chromatography/mass spectrometry (Py-GC/MS). J Hazard Mater. 2024 May 5;469:133855. doi: 10.1016/j.jhazmat.2024.133855. Epub 2024 Feb 21.
PubMed 38428296

Interested in taking part?

Emanuele Barbato, MD, PhD

+39 0633776115

emanuele.barbato@uniroma1.it

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Recruiting
Randomized Prospective Trial on the Cost-Effectiveness of Photon-Counting CT Versus Energy-Integrating Detector CT in Suspected Chronic Coronary Syndrome
Computed Tomography Angiography, Coronary Artery Disease
Not yet recruiting
Community Health Worker Nutrition Self-Management Support for Cardio-Kidney-Metabolic Health
Hypertension (HTN), CKD - Chronic Kidney Disease
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruiting
Out-Patient Proactive Observation With Wearable-Assisted Tracking for Cardiovascular Health Management
Chronic Coronary Syndrome
Not yet recruiting
SWitching to Appropriate Prescription in Cardiovascular-Kidney-Metabolic Syndrome
Cardiovascular-kidney-metabolic Syndrome, Diabete Type 2

All Chronic Coronary Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Microplastics and Nanoplastics in Patients With Chronic Coronary Syndromes
ClinicalTrials.gov ID: NCT07291609
Acronym / sponsor ID: CCS-Plastics / 1000/2025
Conditions: Chronic Coronary Syndrome, Microplastics, Nanoplastics, Coronary Artery Disease, Coronary Plaque, Computed Tomography
Study type: Observational
Recruitment status: Recruiting
Enrolment: 120 participants (estimated)
Lead sponsor: Azienda Ospedaliera "Sant'Andrea"University, hospital or other
Collaborators: University of Campania Luigi Vanvitelli, Azienda Ospedaliera Universitaria Integrata Verona, Morgagni Pierantoni Hospital, Azienda Ospedaliera Sant'Anna e San Sebastiano, Centro Cardiologico Monzino, Milan, Italy
Study start: 1 Jan 2025 (actual)
Primary completion: 31 Dec 2026 (estimated)
Study completion: 31 Dec 2029 (estimated)
First posted: 18 Dec 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 3 Years
Number of arms: 2

Arm	Type	Receives
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 -).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Consecutive patients undergoing coronary CT angiography (CCTA) for suspected or known chronic coronary syndromes (CCS) referred to invasive coronary angiography for clinical indication.

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (5 listed)

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
Life expectancy < 1 year due to non-cardiac pathology

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Burden of micro- and nanoplastics (MNPs) in the coronary blood of patients with chronic coronary syndromes (CCS) and obstructive coronary artery disease (CAD)
Time frame: From enrollment until the date of hospital discharge, assessed up to 7 days
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%)
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.
Time frame: From enrollment until the date of hospital discharge, assessed up to 7 days
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.

21 secondary outcomes

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).
Time frame: From enrollment until the date of hospital discharge, assessed up to 7 days.
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).
Time frame: From enrollment until the date of hospital discharge, assessed up to 7 days
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).
Time frame: From enrollment until the date of hospital discharge, assessed up to 7 days
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).
Time frame: From enrollment until the date of hospital discharge, assessed up to 7 days
Correlation of the burden of micro- and nanoplastics (MNPs) in the coronary blood of patients with chronic coronary syndromes (CCS) with the presence and burden of calcium at coronary computed tomography angiography (CCTA).
Time frame: From enrollment until the date of hospital discharge, assessed up to 7 days.
Correlation of the burden of micro- and nanoplastics (MNPs) in the coronary blood of patients with chronic coronary syndromes (CCS) with the pericoronary fat attenuation index at coronary computed tomography angiography (CCTA).
Time frame: From enrollment until the date of hospital discharge, assessed up to 7 days
Correlation of the burden of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with vessel-specific ischemia.
Time frame: From enrollment until the date of hospital discharge, assessed up to 7 days
Correlation of the burden of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with platelet reactivity
Time frame: From enrollment until the date of hospital discharge, assessed up to 7 days
Correlation of the burden of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with the occurrence of periprocedural events.
Time frame: From enrollment until the date of hospital discharge, assessed up to 7 days
Correlation of the burden of micro- and nanoplastics (MNPs) with major adverse cardiovascular events (cardiovascular death, myocardial infarction, any revascularization, hospitalization for heart failure) at 1-year follow-up.
Time frame: From enrollment to 1-year follow-up.
Correlation of the burden of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with all-cause death at 1-year follow-up.
Time frame: From enrollment to 1-year follow-up.
Correlation of the burden of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with cardiovascular death at 1-year follow-up.
Time frame: From enrollment to 1-year follow-up.
The correlation of the burden of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with myocardial infarction at 1-year follow-up.
Time frame: From enrollment to 1-year follow-up.
The correlation of the burden of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with any revascularization at 1-year follow-up.
Time frame: From enrollment to 1-year follow-up.
Correlation of the burden of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with hospitalization for heart failure at 1-year follow-up.
Time frame: From enrollment to 1-year follow-up.
Correlation of the burden of micro- and nanoplastics (MNPs) with major adverse cardiovascular events (cardiovascular death, myocardial infarction, any revascularization, hospitalization for heart failure) at 3-year follow-up.
Time frame: From enrollment to 3-year follow-up.
Correlation of the burden of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with all-cause death at 3-year follow-up.
Time frame: From enrollment to 3-year follow-up.
Correlation of the burden of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with cardiovascular death at 3-year follow-up.
Time frame: From enrollment to 3-year follow-up.
Correlation of the burden of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with myocardial infarction at 3-year follow-up.
Time frame: From enrollment to 3-year follow-up.
Correlation of the burden of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with any revascularization at 3-year follow-up.
Time frame: From enrollment to 3-year follow-up.
Correlation of the burden of micro- and nanoplastics (MNPs) in patients with chronic coronary syndromes (CCS) with hospitalization for heart failure at 3-year follow-up
Time frame: From enrollment to 3-year follow-up.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
Background: PubMed 39283932Lee DH. Microplastics and Cardiovascular Diseases: Importance of Coexisting Environmental Pollutants. Circulation. 2024 Sep 17;150(12):908-910. doi: 10.1161/CIRCULATIONAHA.124.069801. Epub 2024 Sep 16. No abstract available.
Background: PubMed 38614011Wang T, Yi Z, Liu X, Cai Y, Huang X, Fang J, Shen R, Lu W, Xiao Y, Zhuang W, Guo S. Multimodal detection and analysis of microplastics in human thrombi from multiple anatomically distinct sites. EBioMedicine. 2024 May;103:105118. doi: 10.1016/j.ebiom.2024.105118. Epub 2024 Apr 13.
Background: PubMed 38446676Marfella R, Prattichizzo F, Sardu C, Fulgenzi G, Graciotti L, Spadoni T, D'Onofrio N, Scisciola L, La Grotta R, Frige C, Pellegrini V, Municino M, Siniscalchi M, Spinetti F, Vigliotti G, Vecchione C, Carrizzo A, Accarino G, Squillante A, Spaziano G, Mirra D, Esposito R, Altieri S, Falco G, Fenti A, Galoppo S, Canzano S, Sasso FC, Matacchione G, Olivieri F, Ferraraccio F, Panarese I, Paolisso P, Barbato E, Lubritto C, Balestrieri ML, Mauro C, Caballero AE, Rajagopalan S, Ceriello A, D'Agostino B, Iovino P, Paolisso G. Microplastics and Nanoplastics in Atheromas and Cardiovascular Events. N Engl J Med. 2024 Mar 7;390(10):900-910. doi: 10.1056/NEJMoa2309822.
Background: PubMed 39240674Prattichizzo F, Ceriello A, Pellegrini V, La Grotta R, Graciotti L, Olivieri F, Paolisso P, D'Agostino B, Iovino P, Balestrieri ML, Rajagopalan S, Landrigan PJ, Marfella R, Paolisso G. Micro-nanoplastics and cardiovascular diseases: evidence and perspectives. Eur Heart J. 2024 Oct 7;45(38):4099-4110. doi: 10.1093/eurheartj/ehae552.
Background: PubMed 38428296Liu S, Wang C, Yang Y, Du Z, Li L, Zhang M, Ni S, Yue Z, Yang K, Wang Y, Li X, Yang Y, Qin Y, Li J, Yang Y, Zhang M. Microplastics in three types of human arteries detected by pyrolysis-gas chromatography/mass spectrometry (Py-GC/MS). J Hazard Mater. 2024 May 5;469:133855. doi: 10.1016/j.jhazmat.2024.133855. Epub 2024 Feb 21.
Individual participant dataSharing planned: No

Related trials for Chronic Coronary Syndrome

Recruiting
Randomized Prospective Trial on the Cost-Effectiveness of Photon-Counting CT Versus Energy-Integrating Detector CT in Suspected Chronic Coronary Syndrome
Computed Tomography Angiography, Coronary Artery Disease
Not yet recruiting
Community Health Worker Nutrition Self-Management Support for Cardio-Kidney-Metabolic Health
Hypertension (HTN), CKD - Chronic Kidney Disease
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruiting
Out-Patient Proactive Observation With Wearable-Assisted Tracking for Cardiovascular Health Management
Chronic Coronary Syndrome
Not yet recruiting
SWitching to Appropriate Prescription in Cardiovascular-Kidney-Metabolic Syndrome
Cardiovascular-kidney-metabolic Syndrome, Diabete Type 2

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Emanuele Barbato, MD, PhD contact

+39 0633776115

emanuele.barbato@uniroma1.it

Clinical Research Unit Cardiology Dept. Sant'Andrea University Hospital contact

+39 0633778763

cru.cardiologia@uniroma1.it

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Coronary Syndrome and Microplastics, run by Azienda Ospedaliera "Sant'Andrea" at 6 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Emanuele Barbato, MD, PhD (+39 0633776115, emanuele.barbato@uniroma1.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Burden of micro- and nanoplastics (MNPs) in the coronary blood of patients with chronic coronary syndromes (CCS) and obstructive coronary artery disease (CAD) (time frame: From enrollment until the date of hospital discharge, assessed up to 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07291609, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.