About this trial
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
This trial does not accept healthy volunteersQualifiers
Women and men between 18 and 40 years old with a diagnosis of coronary artery disease coded in their medical records in Galicia
Disqualifiers
Not having a postal code and primary care center assigned in their medical records in Galicia
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
Present with non-ischemic coronary diseas.
Have a serious condition that affects or decreases life expectancy.
Trial 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.
Trial design
Case-control
Retrospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
To determine the differences in exposure to environmental pollutants in patients ≤40 years old with and without coronary artery disease
The study will measure the levels of environmental pollutants (such as PM2.5, PM10, nitrogen dioxide (NO2), carbon monoxide (CO), and ozone (O3), among others) in patients ≤40 years old with a clinical diagnosis of coronary artery disease and in patients without a diagnosis of coronary artery disease, in order to compare the differences.
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
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
To describe the prevalence of CAD in patients ≤40 years old in Galicia
To describe the prevalence of CAD in patients ≤40 years old in Galicia
Secondary outcomes
To evaluate the influence of PM2.5 and PM10 particles on the early manifestation of CAD.
The study will measure the levels of PM2.5, PM10 in patients ≤40 years old with a clinical diagnosis of coronary artery disease and in patients without a diagnosis of coronary artery disease, in order to compare the differences.
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.
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.
To determine the correlation of noise pollution with premature CAD by age and sex.
To determine the correlation of noise pollution with premature CAD by age and sex.
To identify the impact of temperatures on early CAD by age and sex.
The study will determine the impact of extreme temperatures, both heat and cold, on the premature presentation of coronary artery disease, by comparing this exposure between patients with and without the disease and sex.
Sponsors and contacts
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pablo Juan-Salvadores
Lead sponsor
Fundacin Biomedica Galicia Sur
Sponsor institution
Fundacin Biomedica Galicia Sur
Collaborator
Conselleria de Saúde Pública de Galicia
Collaborator
Conselleria de Medio Ambiente, Territorio e Vivenda de Galicia
Collaborator