Pollutants in the Atherosclerotic Plaque and Cardiovascular Events

NCT05900947 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 312

Last updated 2023-10-12

No results posted yet for this study

Summary

Air pollution, microplastics and climate change pose serious public health risks. In recent years, air pollution has been associated with an increased risk of morbidity, all-cause mortality, cardio-respiratory-related mortality, and cancer.

A growing body of evidence has recently confirmed a direct association between particulate matter with an aerodynamic diameter less than or equal to 2.5 mm (PM2.5), Ozone (O3) and aromatic polycyclic hydrocarbons with all-cause mortality irrespective of social context and geographic or economic disparities, suggesting a causal relationship between the two factors.

The effects of air and environmental pollutants on public health have been observed also for short-term exposure to rapid increases in particulate matter.

High PM 2.5 values have also been associated with a higher rate of atherosclerosis and coronary artery disease expressed by high calcium score values, with the elderly, male and diabetic patients being at greater risk. To date, however, the pathophysiological basis of the relationship between air pollutants, and long-term events remains speculative, and there is no evidence that can correlate the concentration of environmental pollutants directly with anatomical-pathological and/or biomolecular alterations.

In this study the investigators will assess the presence and the burden of pollutants within the carotid plaques from patients undergoing carotid endarterectomy with pyrolysis-gas chromatography-mass spectrometry and electronic microscopy. Plaque stability will be explored trough molecular markers. Participants will be followed up for a composite of myocardial infarction, stroke, and all-cause mortality to evaluate whether the presence and the abundance of pollutants are associated with the development of the outcome through adjusted Cox regressions.

Conditions

Interventions

OTHER

analysis of carotid atherosclerotic plaque

To assess the presence of air pollutants (benzene, toluene, xylene, and ethylbenzene) or of microplastics within tissues from atherosclerotic plaques by Chromatographic analyses.

Sponsors & Collaborators

  • Cardarelli Hospital

    collaborator OTHER
  • IRCCS Multimedica

    collaborator OTHER
  • University of Campania Luigi Vanvitelli

    lead OTHER

Principal Investigators

  • Raffaele Marfella, MD,PhD · Università della Campania Vanvitelli

  • Celestino Sardu, MD · Università degli Studi della Campania

  • Francesco Prattichizzo, PhD · IRCCS Multimedica

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2023-07-30
Completion
2023-08-01

Countries

  • Italy

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05900947 on ClinicalTrials.gov