The Cartagena Cohort Study (CaReS)

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Cardiovascular Diseases; Atherosclerosis; COPD; Lung Function Decreased
• Intervention / Treatment: Genetic: Genetic risk variants; Other: Diet; Behavioral: Physical activity; Other: Socio-economic conditions

• Study Type: Observational
• Enrollment (Anticipated): 619

Contacts and Locations

Study Locations

• Colombia
  • Bolivar
    • Cartagena de Indias, Bolivar, Colombia, 130012
      • Universidad de Cartagena

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults, men and women, living on Colombian Caribbean Coast.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

General group; 18-80 years old adults from the Colombian Caribbean Coast.

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).

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Universidad de Cartagena
• Collaborators: Johns Hopkins Bloomberg School of Public Health; University of Chile; The Administrative Department of Science, Technology and Innovation, Colciencias; National Center for Research in Chronic Diseases, Colombia; Universidad Catolica de Cordoba; Universidad de Sucre; Universidad del Magdalena
• Investigators: Principal Investigator: GUSTAVO J MORA-GARCIA, PhD, Universidad de Cartagena; Study Director: VANESSA GARCIA-LARSEN, PhD, BLOOMBERG SCHOOL OF PUBLIC HEALTH JOHNS HOPKINS UNIVERSITY; Study Chair: MARIA S RUIZ-DIAZ, PhD, NATIONAL CENTER FOR RESEARCH IN CHRONIC DISEASES

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2020
• Primary Completion (Anticipated): October 2, 2023
• Study Completion (Anticipated): October 2, 2034

Study Registration Dates

• First Submitted: April 14, 2022
• First Submitted That Met QC Criteria: April 14, 2022
• First Posted (Actual): April 21, 2022

Study Record Updates

• Last Update Posted (Actual): April 21, 2022
• Last Update Submitted That Met QC Criteria: April 14, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Non-communicable diseases; Latin America; Low and middle income countries; Cardio-respiratory disease
• Additional Relevant MeSH Terms: Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Cardiovascular Diseases; Atherosclerosis
• Other Study ID Numbers: CCS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

IPD Plan Description

Documents (i.e., study protocol, informed consent, and laboratory test) and study database are being save on a secure server at https://redcap.unicartagena.edu.co/redcap/

Sharing of study protocol, statistical analysis plan and analytic code is awaiting to be discussed by the research team.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No