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Recruiting NCT06965023

NCT06965023 Microplastics and Nanoplastics (MNPs) in Patients With ST-elevation Myocardial Infarction (STEMI)

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Clinical Trial Summary
NCT ID NCT06965023
Status Recruiting
Phase
Sponsor Azienda Ospedaliera "Sant'Andrea"
Condition ST-elevation Myocardial Infarction (STEMI)
Study Type OBSERVATIONAL
Enrollment 130 participants
Start Date 2025-04-22
Primary Completion 2026-12-30

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type OBSERVATIONAL

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

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 130 participants in total. It began in 2025-04-22 with a primary completion date of 2026-12-30.

⚠ 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

Air pollution and microplastics pose major public health threats. Emerging data have shown that micro- and nanoplastics (MNPs) are ubiquitous environmental pollutants accumulating in human tissues, triggering inflammation and prothrombotic state. This study will investigate the presence and burden of MNPs within coronary thrombi/thromboaspirate of patients presenting with ST segment elevation acute myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention and their association with cardiac damage, plaque vulnerability, microvascular obstruction, and cardiovascular events. Plaque vulnerability will be explored by optical coherence tomography, while microvascular obstruction will be assessed by bolus thermodilution and cardiac magnetic resonance. Participants will be followed up for 1-year to evaluate whether the presence and the burden of MNPs will be associated with a higher incidence of the cardiovascular events.

Eligibility 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.

Contact & Investigator

Central Contact

Emanuele Barbato, MD, PhD

✉ emanuele.barbato@uniroma1.it

📞 +39 0633776115

Principal Investigator

Pasquale Paolisso, MD, PhD

STUDY CHAIR

Sant'Andrea University Hospital

Frequently Asked Questions

Who can join the NCT06965023 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying ST-elevation Myocardial Infarction (STEMI). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06965023 currently recruiting?

Yes, NCT06965023 is actively recruiting participants. Contact the research team at emanuele.barbato@uniroma1.it for enrollment information.

Where is the NCT06965023 trial being conducted?

This trial is being conducted at Roma, Italy, Caserta, Italy, Caserta, Italy, Catania, Italy and 6 additional locations.

Who is sponsoring the NCT06965023 clinical trial?

NCT06965023 is sponsored by Azienda Ospedaliera "Sant'Andrea". The principal investigator is Pasquale Paolisso, MD, PhD at Sant'Andrea University Hospital. The trial plans to enroll 130 participants.

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