Microplastics and nanoplastics in people with chronic coronary syndromes
Microplastics and Nanoplastics in Patients With Chronic Coronary Syndromes
This study will test whether tiny plastic particles (micro- and nanoplastics) can be detected in the coronary blood of adults with suspected or known chronic coronary syndromes who are having coronary CT and invasive angiography.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Azienda Ospedaliera "Sant'Andrea" Academic / other |
| Locations | 6 sites (Caserta and 5 other locations) |
| Trial ID | NCT07291609 on ClinicalTrials.gov |
What this trial studies
This is a prospective, multicenter observational project enrolling adults referred for coronary CT angiography who have a clinical indication for invasive coronary angiography. During invasive angiography, coronary blood samples will be collected and sent to a central core laboratory for centralized analysis of micro- and nanoplastics (MNPs) and related biomarkers. Routine clinical care and treatment decisions will not be changed by participation. Patient dossiers and imaging will be uploaded to a core lab for standardized review and correlation with coronary plaque and stenosis.
Who should consider this trial
Good fit: Adults over 18 with suspected or known chronic coronary syndromes who undergo coronary CT angiography and have a clinical indication for invasive coronary angiography and can give informed consent are ideal candidates.
Not a fit: Patients without a usable coronary CT angiogram, with poor-quality CCTA, without ≥50% native coronary stenosis on CCTA, unable to undergo invasive angiography, or with life expectancy under one year from non-cardiac causes are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the findings could reveal whether micro- and nanoplastics are present in coronary blood and suggest a possible environmental contributor to coronary plaque, informing future prevention or diagnostic work.
How similar studies have performed: This is largely a novel approach in coronary disease: a few early human studies have detected microplastics in blood or tissues, but links to coronary plaque and clinical outcomes remain unproven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: ALL the following: 1. Age \> 18 years old; 2. Suspected or known chronic coronary syndromes undergoing coronary CT angiography; 3. Clinical indication to invasive coronary angiography; 4. Able to give informed consent. Exclusion Criteria: 1. Coronary CT angiography not available; 2. Poor quality CCTA; 3. Absence of native coronary stenosis \>=50% at CCTA; 4. Contraindications to invasive coronary angiography and percutaneous coronary intervention 5. Life expectancy \< 1 year due to non-cardiac pathology
Where this trial is running
Caserta and 5 other locations
- Division of Cardiology, A.O.R.N. "Sant'Anna e San Sebastiano", Caserta, Italy. — Caserta, Italy (Not_yet_recruiting)
- Cardiovascular Division, Morgagni-Pierantoni University Hospital, Forlì, Italy. — Forlì, Italy (Not_yet_recruiting)
- Centro Cardiologico Monzino — Milan, Italy (Active_not_recruiting)
- Department of Advanced Medical and Surgical Sciences, University of Campania-Luigi Vanvitelli, Naples, Italy. — Naples, Italy (Active_not_recruiting)
- Sant'Andrea University Hospital — Roma, Italy (Recruiting)
- Azienda Ospedaliera Integrata Verona, Italy — Verona, Italy (Recruiting)
Study contacts
- Study coordinator: Emanuele Barbato, MD, PhD
- Email: emanuele.barbato@uniroma1.it
- Phone: +39 0633776115
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.