An observational study in Coronary Artery Disease Premature, Angina, Stable and Acute Coronary Syndrome, sponsored by pablo Juan-Salvadores. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2024-06-18.
Sponsored by pablo Juan-Salvadores · Observational
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.
343 studies on the registry are indexed under Angina, Stable; 56 are open to participants now.
This study's planned enrollment of 4,272 is above the median of 508 across 103 observational studies indexed under Angina, Stable.
Browse Angina, Stable studies →This is the only study on the registry with pablo Juan-Salvadores as lead sponsor.
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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.
CASES:
Inclusion Criteria:
Exclusion Criteria:
CONTROL
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients between 18 and 40 years old diagnosed with coronary artery disease, including: ST-elevation myocardial infarction (STEMI), non-ST-elevation acute coronary syndrome (NSTE-ACS), unstable angina, stable angina, MINOCA or silent angina
Patient without coronary artery disease For each case, 3 controls matched by age (±1 year), sex, postal code, and/or primary care center will be included. To avoid the selection of controls that could be associated with an overestimation of exposure to cardiovascular risk factors, the controls will be recruited from the preoperative unit and selected from subjects who have undergone minor clinical procedures (vasectomy, hernia repair, phimosis, prominent ear correction, tubal ligation, euthyroid thyroid nodule, plastic surgery, lipomas, vocal cord cysts, among others), or from the trauma service, selecting those attending for fractures or sprains. This approach ensures a complete medical history along with analytical values in their electronic medical records
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.
Time frame: 15 years
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
Time frame: 15 years
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
Time frame: 15 years
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.
Time frame: 15 years
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.
Time frame: 15 years
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.
Time frame: 15 years
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.
Time frame: 15 years
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).
Time frame: 15 years
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.
Time frame: 15 years
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.
Time frame: 15 years
Plan to share: No
Started May 2024 (actual). Primary completion is estimated for Dec 2024, 7 months after the start.
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