NCT05900947: APAChE

Pollutants in the Atherosclerotic Plaque and Cardiovascular Events

Completed Last updated 12 October 2023

What this trial tests

trial testing analysis of carotid atherosclerotic plaque in Atherosclerosis in 312 participants. Completed in 1 August 2023.

Timeline

1 September 2019

Primary endpoint
30 July 2023

1 August 2023

Quick facts

Lead sponsor	University of Campania Luigi Vanvitelli
Status	Completed
Study type	OBSERVATIONAL
Enrollment	312
Start date	1 September 2019
Primary completion	30 July 2023
Estimated completion	1 August 2023
Sites	1 location across Italy

Drugs / interventions tested

• analysis of carotid atherosclerotic plaque

Conditions studied

• Atherosclerosis — all drugs for Atherosclerosis →

Sponsor

University of Campania Luigi Vanvitelli

Who can join

Adults 18 to 75, any sex, with Atherosclerosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Microplastics and Nanoplastics in Atheromas and Cardiovascular Events.
   Marfella R, Prattichizzo F, Sardu C, Fulgenzi G, et al · · 2024 · cited 629× · PMID 38446676 · DOI 10.1056/nejmoa2309822
2. NLRP3 inflammasome: a key player in the pathogenesis of life-style disorders.
   Ramachandran R, Manan A, Kim J, Choi S. · · 2024 · cited 67× · PMID 38945951 · DOI 10.1038/s12276-024-01261-8
3. Micro(nano)plastics: an Emerging Burden for Human Health.
   Donisi I, Colloca A, Anastasio C, Balestrieri ML, et al · · 2024 · cited 26× · PMID 39494332 · DOI 10.7150/ijbs.99556
4. Detection and Proinflammatory Effects of BTEX within the Human Atherosclerotic Plaque.
   Marfella R, Carreras F, Prattichizzo F, La Grotta R, et al · · 2025 · PMID 41381046 · DOI 10.1021/acs.est.5c04941