Clinical trial NCT05339048: The Cartagena Cohort Study
Official title: Observational Study for the Analysis of Associations Between Cardiovascular and Respiratory Diseases in a Cohort of Latin American Adults
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Cardiovascular Diseases
COPD
Lung Function Decreased
Atherosclerosis
Keywords: Low and middle income countries
Non-communicable diseases
Latin America
Cardio-respiratory disease
Lead sponsor: Universidad de Cartagena
Sponsor class: OTHER
Collaborators: name: The Administrative Department of Science, Technology and Innovation, Colciencias
name: National Center for Research in Chronic Diseases, Colombia
name: Johns Hopkins Bloomberg School of Public Health
name: Universidad Catolica de Cordoba
name: University of Chile
name: Universidad de Sucre
name: Universidad del Magdalena
First posted: 2022-04-21
Enrollment: 619
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults, men and women, living on Colombian Caribbean Coast.

Brief summary: 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.


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

Primary outcomes:
measure: Atherosclerosis
timeFrame: baseline - 10 years (end of follow up)
measure: Acute cardiovascular event
timeFrame: 2nd year (first follow up) - 10 years (end of follow up)
measure: Chronic airflow obstruction
timeFrame: baseline - 10 years (end of follow up)
measure: Metabolic syndrome
timeFrame: baseline - 10 years (end of follow up)
Secondary outcomes:
measure: Chronic Obstructive Pulmonary Disease (COPD)
timeFrame: baseline - 10 years (end of follow up)
measure: Hypertension
timeFrame: baseline - 10 years (end of follow up)
measure: Type 2 Diabetes Mellitus
timeFrame: baseline - 10 years (end of follow up)
measure: Dyslipidemia
timeFrame: baseline - 10 years (end of follow up)
Other outcomes:
Locations:
city: Cartagena de Indias
country: Colombia
facility: Universidad de Cartagena
state: Bolivar
Study officials:
affiliation: Universidad de Cartagena
name: GUSTAVO J MORA-GARCIA, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: BLOOMBERG SCHOOL OF PUBLIC HEALTH JOHNS HOPKINS UNIVERSITY
name: VANESSA GARCIA-LARSEN, PhD
role: STUDY_DIRECTOR
affiliation: NATIONAL CENTER FOR RESEARCH IN CHRONIC DISEASES
name: MARIA S RUIZ-DIAZ, PhD
role: STUDY_CHAIR
References: