Center Protocols

The Argentina Center of Excellence at the South American Center for Cardiovascular Health (SACECH) enacted two protocols:

Protocol 1
Study on the Detection and Follow-up of Cardiovascular Disease and Risk Factors in the Southern Cone of Latin America (CESCAS I)

Protocol 2
Lower respiratory tract illness in children younger than five years of age and adverse pregnancy outcomes related to household indoor air pollution in Bariloche (Argentina) and Temuco (Chile)

Objectives

Protocol 1
To investigate the prevalence and distribution of risk factors, as well as the incidence of cardiovascular and chronic obstructive pulmonary disease in a Latin American population.

Protocol 2
To evaluate whether exposure to indoor air pollution (IAP) affects lower respiratory tract infections (LRTI) and pregnancy outcomes in two locations with high exposure to biomass fuel use in Argentina and Chile.

Background

Protocol 1
Cardiovascular diseases (CVD) and Chronic Obstructive Pulmonary Disease (COPD) represent a growing and global health burden, particularly in economically developing countries. Although age-adjusted rates for CVD mortality have diminished in developed countries, rates have increased in low and middle-income countries reaching 80% of the global burden of disease. The strategies to manage CVDs have largely been developed for populations in high-income countries that are therefore of limited utility in the majority of developing countries. Regardless, there is strong evidence of reducing CVD mortality by modifying three risk factors: smoking, arterial hypertension and high cholesterol. In addition, most CVD occurrence can be explained by other more proximal risk factors such as unhealthy diet, low physical activity and tobacco. COPD incidence in developing countries is largely tied to tobacco use and exposure to second-hand smoke, as well as poor indoor and outdoor air quality.

The Southern Cone is a geographic and cultural region in Latin America generally consisting of Argentina, Chile, and Uruguay, which share similar socio-demographic characteristics. At the time of this study, there had been no longitudinal studies related to the incidence of chronic diseases and risk factors in this region of Latin America. Thus, the understanding of local needs and the data necessary to determine the burden of CVD and COPD, as well as the stratification of risk factors and the identification of management strategies on a population level, were limited. To fill this knowledge gap, the CESCAS I study was intended to generate more precise estimates of the incidence, distribution, and risk factors of CVD and COPD in the southern cone of Latin America.

Protocol 2
Globally about 3 billion people depend on solid fuels for cooking, with 3% of that population living in developing countries from Latin America and the Caribbean. Most households in developing countries use wood as their primary cooking fuel and only 5% of the users of biomass fuels for cooking have access to clean cooking stoves. Preliminary data of PRISA, a population-based cohort study conducted in Argentina, Chile and Uruguay, showed an average exposure to IAP between 21% in Bariloche and 26% in Temuco.

Acute respiratory infections (ARI) represent a common cause of illness in children younger than five years of age in Latin American countries and 12% of deaths for this age group are estimated to be caused by pneumonia. The reduction of IAP related to the use of solid fuels for cooking has been identified as a potential intervention for preventing pneumonia in children. In addition, adverse pregnancy outcomes, such as prematurity or low birth weight, have been linked to exposure to secondhand smoke and ambient air pollution

Participants

Protocol 1
The CESCAS I study intended to recruit 8,000 non-institutionalized adult men and women between the ages of 35 and 74 years old, with 2,000 coming from each of the following sites: Bariloche, Argentina; Marcos Paz, Argentina; Temuco, Chile; and Canelones, Uruguay.

Protocol 2
The study aimed to include 900 households in Bariloche and Temuco, identified by randomized sampling from selected census radii with high exposure to IAP due to solid fuel use. Eligible households included those with children under five years of age, or with a child born alive and/or a stillbirth in the last three years.

Design

Protocol 1
This was an observational prospective cohort study with four years of follow-up, consisting of two phases. In the first phase, baseline data were collected regarding exposure to risk factors and prevalence of cardiovascular and pulmonary disease. Baseline measurements included sociodemographic data, health coverage and utilization, smoking status, alcohol consumption, physical activity, eating habits, quality of life, and self-reported personal and familial disease history. Physical and laboratory measurements included arterial tension, anthropometrical measurements, serum lipids, plasma glucose, serum creatinine, electrocardiography, and spirometry.

In the second phase, follow-up data were obtained on the incidence rate of cardiovascular and pulmonary disease, and the association between exposure and the event. Annual telephone interviews were used to update the baseline data elements, including risk factors and event occurrence. Participants also underwent a clinic visit two years after their initial visit for the purpose of obtaining updated physical measurements, electrocardiogram data, and laboratory measurements. Four years after the initial visit, spirometry was repeated to assess changes in lung function over time and the development of COPD.

Protocol 2
Eligible households were identified though systematic random sampling within a radius of the highest level of exposure to biomass fuels. Investigators used questionnaires to obtain data on medical history related to respiratory infections, pregnancy outcomes, demographic information and smoking habits, from the caregivers of children under five years of age.

The endpoints for lower respiratory tract infections (LTRI) included pneumonia based on recall of the caregiver of key symptoms and signs and the use of antibiotics for treatment within the last year, bronchiolitis based on recall of the caregiver of key symptoms and signs and the treatment with bronchodilator drugs within the last year, LTRI hospitalizations within the child’s lifespan verified by hospital records, and LTRI deaths verified by hospital records or verbal autopsy.

The endpoints for adverse pregnancy outcomes included low birth weight, premature birth, still births (≥ 24 weeks of gestation), and miscarriages within the last three years. Events were reported by the mother, and if possible, confirmed by copies of hospital records available at the home.

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