Investigating microplastics in patients with heart attacks
Microplastics and Nanoplastics (MNPs) in Patients With ST-elevation Myocardial Infarction (STEMI)
Azienda Ospedaliera "Sant'Andrea" · NCT06965023
This study is testing whether tiny plastic particles found in the body affect heart health in patients who have had a heart attack and are getting urgent treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Azienda Ospedaliera "Sant'Andrea" (other) |
| Locations | 10 sites (Roma, Rome and 9 other locations) |
| Trial ID | NCT06965023 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the presence and impact of microplastics and nanoplastics (MNPs) in patients experiencing ST-elevation myocardial infarction (STEMI) who are undergoing urgent coronary intervention. It will assess the burden of MNPs in coronary thrombi and their association with cardiac damage, plaque vulnerability, and cardiovascular events. The study will utilize advanced imaging techniques like optical coherence tomography and cardiac magnetic resonance to evaluate the relationship between MNPs and cardiovascular health over a one-year follow-up period.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who are experiencing a STEMI and require urgent invasive coronary angiography.
Not a fit: Patients with contraindications to percutaneous coronary intervention or those with severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the role of environmental pollutants in heart disease, potentially leading to improved prevention and treatment strategies.
How similar studies have performed: While the investigation of microplastics in human health is emerging, this specific approach in the context of STEMI is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: All the following inclusion criteria should be fulfilled: 1. Age \> 18 years old; 2. STEMI undergoing urgent invasive coronary angiography; 3. Acute thrombotic coronary occlusion/sub-occlusion (TIMI 0/1); 4. Clinical indication to thromboaspiration; 5. Able to give informed consent. Exclusion Criteria: 1. Contraindications to percutaneous coronary intervention; 2. Hemodynamic instability or cardiogenic shock; 3. End-stage chronic kidney disease; 4. Life expectancy \< 1 year due to non-cardiac pathology.
Where this trial is running
Roma, Rome and 9 other locations
- Sant'Andrea University Hospital — Roma, Rome, Italy (RECRUITING)
- Department of Environmental Biological and Pharmaceutical Sciences and Technologies, University of Campania "Luigi Vanvitelli — Caserta, Italy (ACTIVE_NOT_RECRUITING)
- Division of Cardiology, A.O.R.N. "Sant'Anna e San Sebastiano", Caserta, Italy. — Caserta, Italy (NOT_YET_RECRUITING)
- Cardiovascular Department, A.O.U. Policlinico "G. Rodolico - San Marco", University of Catania, Catania, Italy. — Catania, Italy (NOT_YET_RECRUITING)
- Azienda Ospedaliero Universitaria di Ferrara, Cona, Italy — Ferrara, Italy (NOT_YET_RECRUITING)
- Cardiovascular Division, Morgagni-Pierantoni University Hospital, Forlì, Italy. — Forlì, Italy (NOT_YET_RECRUITING)
- Interventional Cardiology Unit, De Gasperis Cardio Center, Niguarda Hospital, Milan, Italy. — Milan, Italy (NOT_YET_RECRUITING)
- Department of Advanced Medical and Surgical Sciences, University of Campania-Luigi Vanvitelli, Naples, Italy. — Naples, Italy (ACTIVE_NOT_RECRUITING)
- Division of Cardiology, Cardiovascular and Thoracic Department, Città della Salute e della Scienza, Turin, Italy. — Turin, Italy (NOT_YET_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.
Conditions: ST-elevation Myocardial Infarction, Microplastics, Nanoplastics, Pollution Exposure, STEMI, Inflammation, OCT, Plaque composition