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Enrolling by invitation NCT05339048

The Cartagena Cohort Study

Observational Cardiovascular Diseases COPD Lung Function Decreased Atherosclerosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Genetic risk variants, Diet, Physical activity, Socio-economic conditions.
Who it may be relevant to
Registry conditions: Cardiovascular Diseases, COPD, Lung Function Decreased, Atherosclerosis. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Colombia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Genetic Genetic risk variants
    Exposure: Genetic predisposition to complex diseases.
  • Other Diet
    Exposure: dietary intake of unhealthy foods known to be associated with higher prevalence of respiratory and cardiovascular diseases.
  • Behavioral Physical activity
    Exposure: frequency of moderated or intense physical activity, and daily exposure to sedentary behavior.
  • Other Socio-economic conditions
    Exposure: socio-economic vulnerability indexes associated with higher prevalence of respiratory and cardiovascular diseases (including household conditions, accessibility to health care services, among others).

Primary outcome measures

  • Atherosclerosis [Time frame: baseline - 10 years (end of follow up)]
  • Acute cardiovascular event [Time frame: 2nd year (first follow up) - 10 years (end of follow up)]
  • Chronic airflow obstruction [Time frame: baseline - 10 years (end of follow up)]
  • Metabolic syndrome [Time frame: baseline - 10 years (end of follow up)]
Secondary outcome measures (4)
  • Chronic Obstructive Pulmonary Disease (COPD) [Time frame: baseline - 10 years (end of follow up)]
  • Hypertension [Time frame: baseline - 10 years (end of follow up)]
  • Type 2 Diabetes Mellitus [Time frame: baseline - 10 years (end of follow up)]
  • Dyslipidemia [Time frame: baseline - 10 years (end of follow up)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Colombia · 1 center
  • Universidad de Cartagena — Cartagena

Identifiers

NCT: NCT05339048 · CCS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗