AtherosclerosisAPAChENCT05900947
Pollutants in the Atherosclerotic Plaque and Cardiovascular Events
An observational study of Atherosclerosis, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- analysis of carotid atherosclerotic plaque
- How many people
- 312 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2019to 1 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
Study population: The study population will include the patients with carotid stenosis (according to North American Symptomatic Carotid Endarterectomy Trial classification) enlisted to undergo carotid endarterectomy for extracranial high-grade (>70%) internal carotid artery stenosis. The patients will be male and female subjects, with age > 18 and < 75 years. We will select patients with asymptomatic carotid disease. All patients will have a baseline clinical examination, and receive computed tomography or MRI to assess cerebral lesions, and previous health records will be evaluated. Clinical variables will be measured with standard procedures after overnight fasting. Patients with diabetes will be categorized according to the ADA criteria.
Who may be able to join
- patients with carotid stenosis (according to North American Symptomatic Carotid Endarterectomy Trial classification) enlisted to undergo carotid endarterectomy for extracranial high-grade (>70%) internal carotid artery stenosis.
Who cannot join
- All patients with clinical or laboratory evidence of heart failure, valvular defects, malignant neoplasms, or secondary causes of hypertension will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Presence of Environmental Pollutants in Human Carotid Atherosclerotic Plaques and Their Relationship With the Plaque Phenotype and Clinical Outcomes
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.
Read more
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.
Read the detailed description
Among patients with carotid stenosis (according to North American Symptomatic Carotid Endarterectomy Trial classification) enlisted to undergo carotid endarterectomy for extracranial high-grade (>70%) internal carotid artery stenosis, the investigators will enroll 300 consecutive patients with asymptomatic disease. All patients will undergo a baseline clinical examination, with computed tomography or MRI to assess cerebral lesions, and health records will be collected. Clinical variables will be measured with standard procedures after overnight fasting. Patients with evidence of heart failure, valvular defects, malignant neoplasms, or secondary causes of hypertension will be excluded.
Specimens of the portion of carotid bifurcation that showed maximum disease will be obtained from atherectomy and will be cut in two halves and frozen in liquid nitrogen or fixed in in 10% buffered formalin for subsequent analyses.
Plaque specimens will be then used to assess the presence and the amount of volatile organic compounds and microplastics through pyrolysis-gas chromatography-mass spectrometry.
To corroborate these findings, plaque specimens will be also observed with transmission electron microscopy to visually identify microplastics within the atheroma and obtain further evidence and structural insights.
Plaques will be also analysed through immunohistochemistry, ELISAs, and Western Blot to quantify inflammatory, i.e. NLRP3, caspase-1, IL-1β, IL-6, TNFα, NF-kB, and CD68, and plaque stability markers, i.e. MMP-9 and collagen, in order to explore whether the presence of microplastics is associated with a poorer plaque phenotype. The groups (composed post-hoc) of patients with polluted plaques vs non-polluted plaques will be compared for the expression of all these markers.
After carotid endarterectomy, patients will be followed-up and monitored for the incidence of a composite outcome constituted by non-fatal myocardial infarction, non-fatal stroke, and all-cause mortality, which represent the main and the only hard endpoint of the study.
Patients will be categorized (post-hoc) as having polluted plaques (having detectable levels of at least one pollutant) or non-polluted plaques. Cox regression analysis will be used to examine the association between the presence of microplastics and the incidence of the composite outcome, adjusted for age, sex, BMI, systolic and diastolic blood pressure, the prevalence of diabetes, dyslipidaemia, and smoking. Among those with polluted plaques, the abundance of pollutants, i.e. the sum, will be used to categorize patients into terciles. Cox models, adjusted for the same variables, will be run to explore the relationship between the burden of microplastics and the outcome. P values < 0.05 will be considered statistically significant.
- Conditions
- Atherosclerosis
- Being tested
- analysis of carotid atherosclerotic plaque
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
analysis of carotid atherosclerotic plaqueOther
To assess the presence of air pollutants (benzene, toluene, xylene, and ethylbenzene) or of microplastics within tissues from atherosclerotic plaques by Chromatographic analyses.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of a composite of myocardial infarction, stroke, and all-cause mortality in patients with polluted vs non-polluted plaques
Patients will be categorized (post-hoc) as having polluted plaques (having detectable levels of at least one microplastics) or non-polluted plaques. Cox regression analysis will be used to examine the association between the presence of pollutants (yes/no) and the incidence of the composite outcome, adjusted for age, sex, BMI, systolic and diastolic blood pressure, the prevalence of diabetes, dyslipidaemia, and smoking.
Measured: 24 months
Secondary outcomes (1)
Incidence of a composite of myocardial infarction, stroke, and all-cause mortality according to terciles of pollutants burden
Among those with polluted plaques, the abundance of pollutants, i.e. the sum, will be used to categorize patients into terciles. Cox models, adjusted for the same variables, will be run to explore the relationship between the burden of microplastics and the outcome. P values < 0.05 will be considered statistically significant.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2023
- Study start1 Sep 2019
- Primary completion30 Jul 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 312 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Collaborators
- Cardarelli Hospital, IRCCS Multimedica
- Responsible party
- Principal investigator, Raffaele Marfella, University of Campania Luigi Vanvitelli
- Investigators
- Raffaele Marfella, MD,PhD, Principal investigator, Università della Campania VanvitelliCelestino Sardu, MD, Study chair, Università degli Studi della CampaniaFrancesco Prattichizzo, PhD, Study chair, IRCCS Multimedica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05900947
- Sponsor's protocol ID
- 2704.2023
- Acronym
- APAChE
- Status last verified
- Oct 2023
- First submitted
- 28 Apr 2023
- Last updated
- 12 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Perera F, Nadeau K. Climate Change, Fossil-Fuel Pollution, and Children's Health. N Engl J Med. 2022 Jun 16;386(24):2303-2314. doi: 10.1056/NEJMra2117706. No abstract available.
PubMed 35704482Lim SS, Vos T, Flaxman AD, Danaei G, Shibuya K, Adair-Rohani H, Amann M, Anderson HR, Andrews KG, Aryee M, Atkinson C, Bacchus LJ, Bahalim AN, Balakrishnan K, Balmes J, Barker-Collo S, Baxter A, Bell ML, Blore JD, Blyth F, Bonner C, Borges G, Bourne R, Boussinesq M, Brauer M, Brooks P, Bruce NG, Brunekreef B, Bryan-Hancock C, Bucello C, Buchbinder R, Bull F, Burnett RT, Byers TE, Calabria B, Carapetis J, Carnahan E, Chafe Z, Charlson F, Chen H, Chen JS, Cheng AT, Child JC, Cohen A, Colson KE, Cowie BC, Darby S, Darling S, Davis A, Degenhardt L, Dentener F, Des Jarlais DC, Devries K, Dherani M, Ding EL, Dorsey ER, Driscoll T, Edmond K, Ali SE, Engell RE, Erwin PJ, Fahimi S, Falder G, Farzadfar F, Ferrari A, Finucane MM, Flaxman S, Fowkes FG, Freedman G, Freeman MK, Gakidou E, Ghosh S, Giovannucci E, Gmel G, Graham K, Grainger R, Grant B, Gunnell D, Gutierrez HR, Hall W, Hoek HW, Hogan A, Hosgood HD 3rd, Hoy D, Hu H, Hubbell BJ, Hutchings SJ, Ibeanusi SE, Jacklyn GL, Jasrasaria R, Jonas JB, Kan H, Kanis JA, Kassebaum N, Kawakami N, Khang YH, Khatibzadeh S, Khoo JP, Kok C, Laden F, Lalloo R, Lan Q, Lathlean T, Leasher JL, Leigh J, Li Y, Lin JK, Lipshultz SE, London S, Lozano R, Lu Y, Mak J, Malekzadeh R, Mallinger L, Marcenes W, March L, Marks R, Martin R, McGale P, McGrath J, Mehta S, Mensah GA, Merriman TR, Micha R, Michaud C, Mishra V, Mohd Hanafiah K, Mokdad AA, Morawska L, Mozaffarian D, Murphy T, Naghavi M, Neal B, Nelson PK, Nolla JM, Norman R, Olives C, Omer SB, Orchard J, Osborne R, Ostro B, Page A, Pandey KD, Parry CD, Passmore E, Patra J, Pearce N, Pelizzari PM, Petzold M, Phillips MR, Pope D, Pope CA 3rd, Powles J, Rao M, Razavi H, Rehfuess EA, Rehm JT, Ritz B, Rivara FP, Roberts T, Robinson C, Rodriguez-Portales JA, Romieu I, Room R, Rosenfeld LC, Roy A, Rushton L, Salomon JA, Sampson U, Sanchez-Riera L, Sanman E, Sapkota A, Seedat S, Shi P, Shield K, Shivakoti R, Singh GM, Sleet DA, Smith E, Smith KR, Stapelberg NJ, Steenland K, Stockl H, Stovner LJ, Straif K, Straney L, Thurston GD, Tran JH, Van Dingenen R, van Donkelaar A, Veerman JL, Vijayakumar L, Weintraub R, Weissman MM, White RA, Whiteford H, Wiersma ST, Wilkinson JD, Williams HC, Williams W, Wilson N, Woolf AD, Yip P, Zielinski JM, Lopez AD, Murray CJ, Ezzati M, AlMazroa MA, Memish ZA. A comparative risk assessment of burden of disease and injury attributable to 67 risk factors and risk factor clusters in 21 regions, 1990-2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012 Dec 15;380(9859):2224-60. doi: 10.1016/S0140-6736(12)61766-8.
PubMed 23245609Di Q, Wang Y, Zanobetti A, Wang Y, Koutrakis P, Choirat C, Dominici F, Schwartz JD. Air Pollution and Mortality in the Medicare Population. N Engl J Med. 2017 Jun 29;376(26):2513-2522. doi: 10.1056/NEJMoa1702747.
PubMed 28657878Bevan GH, Al-Kindi SG, Brook RD, Munzel T, Rajagopalan S. Ambient Air Pollution and Atherosclerosis: Insights Into Dose, Time, and Mechanisms. Arterioscler Thromb Vasc Biol. 2021 Feb;41(2):628-637. doi: 10.1161/ATVBAHA.120.315219. Epub 2020 Dec 17.
PubMed 33327745Marfella R, Prattichizzo F, Sardu C, Fulgenzi G, Graciotti L, Spadoni T, D'Onofrio N, Scisciola L, La Grotta R, Frige C, Pellegrini V, Municino M, Siniscalchi M, Spinetti F, Vigliotti G, Vecchione C, Carrizzo A, Accarino G, Squillante A, Spaziano G, Mirra D, Esposito R, Altieri S, Falco G, Fenti A, Galoppo S, Canzano S, Sasso FC, Matacchione G, Olivieri F, Ferraraccio F, Panarese I, Paolisso P, Barbato E, Lubritto C, Balestrieri ML, Mauro C, Caballero AE, Rajagopalan S, Ceriello A, D'Agostino B, Iovino P, Paolisso G. Microplastics and Nanoplastics in Atheromas and Cardiovascular Events. N Engl J Med. 2024 Mar 7;390(10):900-910. doi: 10.1056/NEJMoa2309822.
PubMed 38446676
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Presence of Environmental Pollutants in Human Carotid Atherosclerotic Plaques and Their Relationship With the Plaque Phenotype and Clinical Outcomes
- ClinicalTrials.gov ID
- NCT05900947
- Acronym / sponsor ID
- APAChE / 2704.2023
- Conditions
- Atherosclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Collaborators
- Cardarelli Hospital, IRCCS Multimedica
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 13 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Among patients with carotid stenosis (according to North American Symptomatic Carotid Endarterectomy Trial classification) enlisted to undergo carotid endarterectomy for extracranial high-grade (>70%) internal carotid artery stenosis, the investigators will enroll 300 consecutive patients with asymptomatic disease. All patients will undergo a baseline clinical examination, with computed tomography or MRI to assess cerebral lesions, and health records will be collected. Clinical variables will be measured with standard procedures after overnight fasting. Patients with evidence of heart failure, valvular defects, malignant neoplasms, or secondary causes of hypertension will be excluded.
Specimens of the portion of carotid bifurcation that showed maximum disease will be obtained from atherectomy and will be cut in two halves and frozen in liquid nitrogen or fixed in in 10% buffered formalin for subsequent analyses.
Plaque specimens will be then used to assess the presence and the amount of volatile organic compounds and microplastics through pyrolysis-gas chromatography-mass spectrometry.
To corroborate these findings, plaque specimens will be also observed with transmission electron microscopy to visually identify microplastics within the atheroma and obtain further evidence and structural insights.
Plaques will be also analysed through immunohistochemistry, ELISAs, and Western Blot to quantify inflammatory, i.e. NLRP3, caspase-1, IL-1β, IL-6, TNFα, NF-kB, and CD68, and plaque stability markers, i.e. MMP-9 and collagen, in order to explore whether the presence of microplastics is associated with a poorer plaque phenotype. The groups (composed post-hoc) of patients with polluted plaques vs non-polluted plaques will be compared for the expression of all these markers.
After carotid endarterectomy, patients will be followed-up and monitored for the incidence of a composite outcome constituted by non-fatal myocardial infarction, non-fatal stroke, and all-cause mortality, which represent the main and the only hard endpoint of the study.
Patients will be categorized (post-hoc) as having polluted plaques (having detectable levels of at least one pollutant) or non-polluted plaques. Cox regression analysis will be used to examine the association between the presence of microplastics and the incidence of the composite outcome, adjusted for age, sex, BMI, systolic and diastolic blood pressure, the prevalence of diabetes, dyslipidaemia, and smoking. Among those with polluted plaques, the abundance of pollutants, i.e. the sum, will be used to categorize patients into terciles. Cox models, adjusted for the same variables, will be run to explore the relationship between the burden of microplastics and the outcome. P values < 0.05 will be considered statistically significant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population will include the patients with carotid stenosis (according to North American Symptomatic Carotid Endarterectomy Trial classification) enlisted to undergo carotid endarterectomy for extracranial high-grade (>70%) internal carotid artery stenosis. The patients will be male and female subjects, with age > 18 and < 75 years. We will select patients with asymptomatic carotid disease. All patients will have a baseline clinical examination, and receive computed tomography or MRI to assess cerebral lesions, and previous health records will be evaluated. Clinical variables will be measured with standard procedures after overnight fasting. Patients with diabetes will be categorized according to the ADA criteria.
Key inclusion criteria (1 listed)
- patients with carotid stenosis (according to North American Symptomatic Carotid Endarterectomy Trial classification) enlisted to undergo carotid endarterectomy for extracranial high-grade (>70%) internal carotid artery stenosis.
Key exclusion criteria (1 listed)
- All patients with clinical or laboratory evidence of heart failure, valvular defects, malignant neoplasms, or secondary causes of hypertension will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| analysis of carotid atherosclerotic plaqueTo assess the presence of air pollutants (benzene, toluene, xylene, and ethylbenzene) or of microplastics within tissues from atherosclerotic plaques by Chromatographic analyses. | Other | – |
Primary outcome
Incidence of a composite of myocardial infarction, stroke, and all-cause mortality in patients with polluted vs non-polluted plaques
Time frame: 24 months
Patients will be categorized (post-hoc) as having polluted plaques (having detectable levels of at least one microplastics) or non-polluted plaques. Cox regression analysis will be used to examine the association between the presence of pollutants (yes/no) and the incidence of the composite outcome, adjusted for age, sex, BMI, systolic and diastolic blood pressure, the prevalence of diabetes, dyslipidaemia, and smoking.
1 secondary outcome
Incidence of a composite of myocardial infarction, stroke, and all-cause mortality according to terciles of pollutants burden
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
- Background: PubMed 35704482Perera F, Nadeau K. Climate Change, Fossil-Fuel Pollution, and Children's Health. N Engl J Med. 2022 Jun 16;386(24):2303-2314. doi: 10.1056/NEJMra2117706. No abstract available.
- Background: PubMed 23245609Lim SS, Vos T, Flaxman AD, Danaei G, Shibuya K, Adair-Rohani H, Amann M, Anderson HR, Andrews KG, Aryee M, Atkinson C, Bacchus LJ, Bahalim AN, Balakrishnan K, Balmes J, Barker-Collo S, Baxter A, Bell ML, Blore JD, Blyth F, Bonner C, Borges G, Bourne R, Boussinesq M, Brauer M, Brooks P, Bruce NG, Brunekreef B, Bryan-Hancock C, Bucello C, Buchbinder R, Bull F, Burnett RT, Byers TE, Calabria B, Carapetis J, Carnahan E, Chafe Z, Charlson F, Chen H, Chen JS, Cheng AT, Child JC, Cohen A, Colson KE, Cowie BC, Darby S, Darling S, Davis A, Degenhardt L, Dentener F, Des Jarlais DC, Devries K, Dherani M, Ding EL, Dorsey ER, Driscoll T, Edmond K, Ali SE, Engell RE, Erwin PJ, Fahimi S, Falder G, Farzadfar F, Ferrari A, Finucane MM, Flaxman S, Fowkes FG, Freedman G, Freeman MK, Gakidou E, Ghosh S, Giovannucci E, Gmel G, Graham K, Grainger R, Grant B, Gunnell D, Gutierrez HR, Hall W, Hoek HW, Hogan A, Hosgood HD 3rd, Hoy D, Hu H, Hubbell BJ, Hutchings SJ, Ibeanusi SE, Jacklyn GL, Jasrasaria R, Jonas JB, Kan H, Kanis JA, Kassebaum N, Kawakami N, Khang YH, Khatibzadeh S, Khoo JP, Kok C, Laden F, Lalloo R, Lan Q, Lathlean T, Leasher JL, Leigh J, Li Y, Lin JK, Lipshultz SE, London S, Lozano R, Lu Y, Mak J, Malekzadeh R, Mallinger L, Marcenes W, March L, Marks R, Martin R, McGale P, McGrath J, Mehta S, Mensah GA, Merriman TR, Micha R, Michaud C, Mishra V, Mohd Hanafiah K, Mokdad AA, Morawska L, Mozaffarian D, Murphy T, Naghavi M, Neal B, Nelson PK, Nolla JM, Norman R, Olives C, Omer SB, Orchard J, Osborne R, Ostro B, Page A, Pandey KD, Parry CD, Passmore E, Patra J, Pearce N, Pelizzari PM, Petzold M, Phillips MR, Pope D, Pope CA 3rd, Powles J, Rao M, Razavi H, Rehfuess EA, Rehm JT, Ritz B, Rivara FP, Roberts T, Robinson C, Rodriguez-Portales JA, Romieu I, Room R, Rosenfeld LC, Roy A, Rushton L, Salomon JA, Sampson U, Sanchez-Riera L, Sanman E, Sapkota A, Seedat S, Shi P, Shield K, Shivakoti R, Singh GM, Sleet DA, Smith E, Smith KR, Stapelberg NJ, Steenland K, Stockl H, Stovner LJ, Straif K, Straney L, Thurston GD, Tran JH, Van Dingenen R, van Donkelaar A, Veerman JL, Vijayakumar L, Weintraub R, Weissman MM, White RA, Whiteford H, Wiersma ST, Wilkinson JD, Williams HC, Williams W, Wilson N, Woolf AD, Yip P, Zielinski JM, Lopez AD, Murray CJ, Ezzati M, AlMazroa MA, Memish ZA. A comparative risk assessment of burden of disease and injury attributable to 67 risk factors and risk factor clusters in 21 regions, 1990-2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012 Dec 15;380(9859):2224-60. doi: 10.1016/S0140-6736(12)61766-8.
- Background: PubMed 28657878Di Q, Wang Y, Zanobetti A, Wang Y, Koutrakis P, Choirat C, Dominici F, Schwartz JD. Air Pollution and Mortality in the Medicare Population. N Engl J Med. 2017 Jun 29;376(26):2513-2522. doi: 10.1056/NEJMoa1702747.
- Background: PubMed 33327745Bevan GH, Al-Kindi SG, Brook RD, Munzel T, Rajagopalan S. Ambient Air Pollution and Atherosclerosis: Insights Into Dose, Time, and Mechanisms. Arterioscler Thromb Vasc Biol. 2021 Feb;41(2):628-637. doi: 10.1161/ATVBAHA.120.315219. Epub 2020 Dec 17.
- Derived from this study: PubMed 38446676Marfella R, Prattichizzo F, Sardu C, Fulgenzi G, Graciotti L, Spadoni T, D'Onofrio N, Scisciola L, La Grotta R, Frige C, Pellegrini V, Municino M, Siniscalchi M, Spinetti F, Vigliotti G, Vecchione C, Carrizzo A, Accarino G, Squillante A, Spaziano G, Mirra D, Esposito R, Altieri S, Falco G, Fenti A, Galoppo S, Canzano S, Sasso FC, Matacchione G, Olivieri F, Ferraraccio F, Panarese I, Paolisso P, Barbato E, Lubritto C, Balestrieri ML, Mauro C, Caballero AE, Rajagopalan S, Ceriello A, D'Agostino B, Iovino P, Paolisso G. Microplastics and Nanoplastics in Atheromas and Cardiovascular Events. N Engl J Med. 2024 Mar 7;390(10):900-910. doi: 10.1056/NEJMoa2309822.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raffaele Marfella, MD,PhD principal investigator
Università della Campania Vanvitelli
Celestino Sardu, MD study chair
Università degli Studi della Campania
Francesco Prattichizzo, PhD study chair
IRCCS Multimedica
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerosis, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of a composite of myocardial infarction, stroke, and all-cause mortality in patients with polluted vs non-polluted plaques (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05900947, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2023.