Influence of Air Quality on the Development and Progression of Premature Coronary Artery Disease

Myocardial Infarction Clinical Trial

— AIRHEART  

Official title:

Influence of Air Quality on the Development and Progression of Premature Coronary Artery Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06464042
• Other study ID #: AirHeart Study
• Secondary ID: SEC/FEC-INV-CLI
• Status: Recruiting
• Start date: May 23, 2024
• Est. completion date: July 1, 2025

Study information

• Verified date: June 2024
• Source: Fundacin Biomedica Galicia Sur
• Contact: Pablo Juan-Salvadores, Pharma, PhD
• Phone: +34986825564
• Email: pablo.juan[@]iisgaliciasur.es
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4272
• Est. completion date: July 1, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Angina, Stable
• Coronary Artery Disease
• Coronary Disease
• Infarction
• Myocardial Infarction
• Myocardial Ischemia
• Premature Birth

Locations

Country	Name	City	State
Spain	Hospital Álvaro Cunqueiro	Vigo	Pontevedra

Sponsors (4)

Lead Sponsor	Collaborator
pablo Juan-Salvadores	Conselleria de Medio Ambiente, Territorio e Vivenda de Galicia, Conselleria de Saúde Pública de Galicia, Fundacin Biomedica Galicia Sur

Country where clinical trial is conducted

Spain, 

References & Publications (7)

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.2016 — View 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. — View 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. — View 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. — View 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. — View 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 Pol — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	15 years
Primary	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	15 years
Primary	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	15 years
Secondary	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.	15 years
Secondary	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.	15 years
Secondary	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.	15 years
Secondary	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.	15 years
Secondary	To determine the correlation of environmental pollutants in patients with myocardial infarction with non-obstructive coronary arteries (MINOCA).	To determine the correlation of environmental pollutants in patients with myocardial infarction with non-obstructive coronary arteries (MINOCA).	15 years
Secondary	To compare the effect of environmental pollutants and their relationship with CAD between men and women.	The influence of different environmental pollutants on the premature presentation of coronary artery disease will be analyzed, taking into account the differences between women and men.	15 years
Secondary	To evaluate the incidence of serious adverse events	To evaluate the incidence of recurrent myocardial infarction, revascularizations (unplanned after admission), stroke, death, major bleeding (BARC scale 2 or higher), hospital admission for stable angina, unstable angina, acute coronary syndrome with or without ST elevation, congestive heart failure (CHF), or heart transplant during 1, 5, and 10 years. By age and sex.	15 years

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