Clinical trial NCT06464042: Influence of Air Quality on the Development and Progression of Premature Coronary Artery Disease
Official title: Influence of Air Quality on the Development and Progression of Premature Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease Premature
Angina, Stable
Acute Coronary Syndrome
MINOCA
Myocardial Infarction
Keywords: Air pollution
young
Coronary Artery Disease Premature
Lead sponsor: Fundacin Biomedica Galicia Sur
Sponsor class: OTHER
Collaborators: name: Fundacin Biomedica Galicia Sur
name: Conselleria de Saúde Pública de Galicia
name: Conselleria de Medio Ambiente, Territorio e Vivenda de Galicia
First posted: 2024-06-18
Enrollment: 4272
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study focuses on patients aged ≤40 years with a diagnosis of coronary artery disease (CAD) recorded in the clinical history of Galicia (IANUS), including: ST-elevation myocardial infarction (STEMI), non-ST-elevation acute coronary syndrome (NSTACS), unstable angina, stable angina, or silent angina according to the International Classification of Diseases (ICD-10). Given the limited number of cases, to increase the statistical power of the project, three patients without a diagnosis of CAD (controls) will be used for each patient with CAD confirmed by coronary angiography (case), matched by postal code and primary care center.

Brief summary: The new global guidelines from the World Health Organization on air quality provide evidence of the damage that air pollution inflicts on human health at even lower concentrations than previously thought. Different studies have shown an increase in the incidence of coronary artery disease (CAD) in young people in recent decades. The main objective of this project is to study the impact of environmental pollutants on the premature manifestation of CAD from different epidemiological approaches and their impact on the evolution of these patients with a gender perspective. It is a retrospective analytical case-control study nested in a cohort of patients ≤40 years old with a clinical history of CAD including: ST-segment elevation myocardial infarction, non-ST-segment elevation acute coronary syndrome, unstable angina, stable angina or silent angina according to the international classification of diseases.


Eligibility criteria: CASES:

Inclusion Criteria:

* Women and men between 18 and 40 years old with a diagnosis of coronary artery disease coded in their medical records in Galicia

Exclusion Criteria:

* Not having a postal code and primary care center assigned in their medical records in Galicia

CONTROL

Inclusion Criteria:

* Women and men between 18 and 40 years old with no diagnosis or history of CAD or other coronary disease coded in their medical records

Exclusion Criteria:

* Present with non-ischemic coronary diseas.
* Have a serious condition that affects or decreases life expectancy.
* Do not have a postal code or primary care center assigned in their medical records in Galicia

Primary outcomes:
measure: To determine the differences in exposure to environmental pollutants in patients ≤40 years old with and without coronary artery disease
timeFrame: 15 years
measure: To evaluate the impact of environmental pollutants on the incidence of the combined variable of major adverse cardiovascular events (MACE) up to 1, 5, and 10 years from the index cas
timeFrame: 15 years
measure: To describe the prevalence of CAD in patients ≤40 years old in Galicia
timeFrame: 15 years
Secondary outcomes:
measure: To evaluate the influence of PM2.5 and PM10 particles on the early manifestation of CAD.
timeFrame: 15 years
measure: To describe the prevalence of ozone (O3), nitrogen dioxide (NO2), sulfur dioxide (SO2), benzene (C6H6), carbon monoxide (CO), and heavy metals such as arsenic, cadmium, nickel, and lead in the premature manifestation of CAD.
timeFrame: 15 years
measure: To determine the correlation of noise pollution with premature CAD by age and sex.
timeFrame: 15 years
measure: To identify the impact of temperatures on early CAD by age and sex.
timeFrame: 15 years
measure: To determine the correlation of environmental pollutants in patients with myocardial infarction with non-obstructive coronary arteries (MINOCA).
timeFrame: 15 years
measure: To compare the effect of environmental pollutants and their relationship with CAD between men and women.
timeFrame: 15 years
measure: To evaluate the incidence of serious adverse events
timeFrame: 15 years
Other outcomes:
Locations:
city: Vigo
country: Spain
facility: Hospital Álvaro Cunqueiro
state: Pontevedra
Study officials:
affiliation: Instituto de Investigación Sanitaria Galicia Sur (IIS Galicia Sur)
name: Pablo Juan-Salvadores, Pharma, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Juan-Salvadores P, Veiga C, Jimenez Diaz VA, Guitian Gonzalez A, Iglesia Carreno C, Martinez Reglero C, Baz Alonso JA, Caamano Isorna F, Romo AI. Using Machine Learning Techniques to Predict MACE in Very Young Acute Coronary Syndrome Patients. Diagnostics (Basel). 2022 Feb 6;12(2):422. doi: 10.3390/diagnostics12020422.
citation: Juan-Salvadores P, Jimenez Diaz VA, Iglesia Carreno C, Guitian Gonzalez A, Veiga C, Martinez Reglero C, Baz Alonso JA, Caamano Isorna F, Iniguez Romo A. Coronary Artery Disease in Very Young Patients: Analysis of Risk Factors and Long-Term Follow-Up. J Cardiovasc Dev Dis. 2022 Mar 11;9(3):82. doi: 10.3390/jcdd9030082.
citation: Juan-Salvadores P, Jimenez Diaz VA, Rodriguez Gonzalez de Araujo A, Iglesia Carreno C, Guitian Gonzalez A, Veiga Garcia C, Baz Alonso JA, Caamano Isorna F, Iniguez Romo A. Clinical Features and Long-Term Outcomes in Very Young Patients with Myocardial Infarction with Non-Obstructive Coronary Arteries. J Interv Cardiol. 2022 Jul 30;2022:9584527. doi: 10.1155/2022/9584527. eCollection 2022.
citation: Chen R, Yin P, Meng X, Liu C, Wang L, Xu X, Ross JA, Tse LA, Zhao Z, Kan H, Zhou M. Fine Particulate Air Pollution and Daily Mortality. A Nationwide Analysis in 272 Chinese Cities. Am J Respir Crit Care Med. 2017 Jul 1;196(1):73-81. doi: 10.1164/rccm.201609-1862OC.
citation: Orellano P, Reynoso J, Quaranta N, Bardach A, Ciapponi A. Short-term exposure to particulate matter (PM10 and PM2.5), nitrogen dioxide (NO2), and ozone (O3) and all-cause and cause-specific mortality: Systematic review and meta-analysis. Environ Int. 2020 Sep;142:105876. doi: 10.1016/j.envint.2020.105876. Epub 2020 Jun 23.
citation: Kirwa K, Szpiro AA, Sheppard L, Sampson PD, Wang M, Keller JP, Young MT, Kim SY, Larson TV, Kaufman JD. Fine-Scale Air Pollution Models for Epidemiologic Research: Insights From Approaches Developed in the Multi-ethnic Study of Atherosclerosis and Air Pollution (MESA Air). Curr Environ Health Rep. 2021 Jun;8(2):113-126. doi: 10.1007/s40572-021-00310-y.
citation: Chen SY, Hwang JS, Chan CC, Wu CF, Wu C, Su TC. Urban Air Pollution and Subclinical Atherosclerosis in Adolescents and Young Adults. J Adolesc Health. 2022 Aug;71(2):233-238. doi: 10.1016/j.jadohealth.2022.03.004. Epub 2022 May 7.