NCT07291609 Microplastics and Nanoplastics in Patients With Chronic Coronary Syndromes
| NCT ID | NCT07291609 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Azienda Ospedaliera "Sant'Andrea" |
| Condition | Chronic Coronary Syndrome |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2025-01-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07291609 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Coronary Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07291609 currently recruiting?
Yes, NCT07291609 is actively recruiting participants. Contact the research team at emanuele.barbato@uniroma1.it for enrollment information.
Where is the NCT07291609 trial being conducted?
This trial is being conducted at Caserta, Italy, Forlì, Italy, Milan, Italy, Naples, Italy and 2 additional locations.
Who is sponsoring the NCT07291609 clinical trial?
NCT07291609 is sponsored by Azienda Ospedaliera "Sant'Andrea". The trial plans to enroll 120 participants.