The Cartagena Cohort Study

Study Overview
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Brief Summary
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Cardiovascular and respiratory diseases are the first and third cause of death, respectively. Cardiovascular risk is known to increase in groups with impaired lung function; however, the mechanisms behind this association are not fully understood. The aim of CaReS is to elucidate the shared pathophysiology of impaired lung function and cardiovascular risk, and to investigate the risk factors associated with them. The CaReS Cohort Study includes adults (18-80 years old) from Cartagena de Indias, a tropical city on Colombian Caribbean Coast, where recent population admixture settled a three-hybrid genetic structure (European, African and Ameridian ancestry). At baseline, the cohort will generate extensive data on -omics (e.g., genomics, transcriptomics, metabolomics, and epigenomics), socio-economic wellbeing, lifestyle, medical history, cardiometabolic, inflammatory and liver function markers, as well as objective measures of ventilatory and cardiovascular performance. The cohort will collect data every three years, for a total period of ten years. Prospective risk of cardiovascular disease and chronic obstructive pulmonary disease (COPD) will be investigated, and their risk factors. Throughout the study period, changes in prevalence, and interactions of various risk factors with these changes will also be ascertained. A predictive risk score for cardiovascular and chronic respiratory disability will be built, using cross-sectional and longitudinal data.

Official Title
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Observational Study for the Analysis of Associations Between Cardiovascular and Respiratory Diseases in a Cohort of Latin American Adults

Conditions
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Cardiovascular Diseases, COPD, Lung Function Decreased, Atherosclerosis

Intervention / Treatment
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* Genetic: Genetic risk variants
* Other: Diet
* Behavioral: Physical activity
* Other: Socio-economic conditions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults Native from Colombian Caribbean Coast Exclusion Criteria: Pregnant women Walking physical disability Cognitive disability Patients under treatment for any type of cancer Clinical record of primary chronic endocrine disease Clinical record of major respiratory tract surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| General group<br>18-80 years old adults from the Colombian Caribbean Coast. | Genetic: Genetic risk variants<br>* Exposure: Genetic predisposition to complex diseases.<br>Other: Diet<br>* Exposure: dietary intake of unhealthy foods known to be associated with higher prevalence of respiratory and cardiovascular diseases.<br>Behavioral: Physical activity<br>* Exposure: frequency of moderated or intense physical activity, and daily exposure to sedentary behavior.<br>Other: Socio-economic conditions<br>* Exposure: socio-economic vulnerability indexes associated with higher prevalence of respiratory and cardiovascular diseases (including household conditions, accessibility to health care services, among others).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atherosclerosis | Carotid atheroma identified by eco-doppler imaging test | baseline - 10 years (end of follow up) | 
| Acute cardiovascular event | Record of acute coronary heart disease, miocardipathy, and ischemic or hemorragic cerebrovascular event. | 2nd year (first follow up) - 10 years (end of follow up) | 
| Chronic airflow obstruction | Obstruction patterns in post-bronchodilator spirometry. | baseline - 10 years (end of follow up) | 
| Metabolic syndrome | Pathologic findings for blood pressure, triglycerides, HDLc, serum glucose, and/or enlarged waist circumference (three or more of this criteria found simultaneously) | baseline - 10 years (end of follow up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic Obstructive Pulmonary Disease (COPD) | Diagnosis of by lung function test (post-bronchodilator spirometry) and/or clinical criteria | baseline - 10 years (end of follow up) | 
| Hypertension | Primary high blood pressure according to clinical criteria | baseline - 10 years (end of follow up) | 
| Type 2 Diabetes Mellitus | Abnormal results in fasting serum glucose test and/or HbA1c test. | baseline - 10 years (end of follow up) | 
| Dyslipidemia | High serum cholesterol, triglycerides or LDLc; and/or low HDLc | baseline - 10 years (end of follow up) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low and middle income countries, Non-communicable diseases, Latin America, Cardio-respiratory disease