Microplastics and Nanoplastics in Patients With Chronic Coronary Syndromes (NCT07291609) | Clinical Trial Compass
RecruitingNot Applicable
Microplastics and Nanoplastics in Patients With Chronic Coronary Syndromes
Italy120 participantsStarted 2025-01-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. Coronary CT angiography not available;
. Poor quality CCTA;
. Absence of native coronary stenosis \>=50% at CCTA;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is measuring microplastics and nanoplastics found directly in coronary blood — does my specific diagnosis of chronic coronary syndrome and the type of plaque I have make me someone worth discussing this trial with?
2Since this is listed as phase 'NA,' it sounds like an observational study rather than a treatment trial — can you help me understand what would actually be done to me, such as blood draws or a CT angiogram, and whether those procedures carry any additional risks beyond what I'd face in routine care?
3The trial is looking at pollution exposure as a factor in coronary artery disease — given my personal history and environment, is this the kind of research where my participation could genuinely help doctors understand what's driving plaque buildup in patients like me?
4Would enrolling in this study in any way delay, replace, or interfere with the standard treatment plan you're already recommending for my coronary artery disease?
5Are there things about my current medications, prior procedures, or overall health that might make me ineligible or that I should flag before we seriously consider whether this trial is a good fit for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Burden of micro- and nanoplastics (MNPs) in the coronary blood of patients with chronic coronary syndromes (CCS) and obstructive coronary artery disease (CAD)
Timeframe: 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.
Timeframe: From enrollment until the date of hospital discharge, assessed up to 7 days