The Cartagena Cohort Study

NCT05339048 | Enrolling By Invitation

• 1 other identifier: CCS
• Study Type: observational
• Target: 619
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases; COPD; Lung Function Decreased; Atherosclerosis

Keywords

Low and middle income countries; Non-communicable diseases; Latin America; Cardio-respiratory disease

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Chronic Obstructive Pulmonary Disease (COPD)

  baseline - 10 years (end of follow up)

• Hypertension

  baseline - 10 years (end of follow up)

• Type 2 Diabetes Mellitus

  baseline - 10 years (end of follow up)

• Dyslipidemia

  baseline - 10 years (end of follow up)

Study Arms (1)

General group

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

Genetic: Genetic risk variants; Other: Diet; Behavioral: Physical activity; Other: Socio-economic conditions

Interventions

Genetic risk variants GENETIC

Exposure: Genetic predisposition to complex diseases.

General group

Diet OTHER

Exposure: dietary intake of unhealthy foods known to be associated with higher prevalence of respiratory and cardiovascular diseases.

General group

Physical activity BEHAVIORAL

Exposure: frequency of moderated or intense physical activity, and daily exposure to sedentary behavior.

General group

Socio-economic conditions OTHER

Exposure: socio-economic vulnerability indexes associated with higher prevalence of respiratory and cardiovascular diseases (including household conditions, accessibility to health care services, among others).

General group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Adults
• Native from Colombian Caribbean Coast

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de Cartagena: lead
• The Administrative Department of Science, Technology and Innovation, Colciencias: collaborator
• National Center for Research in Chronic Diseases, Colombia: collaborator
• Johns Hopkins Bloomberg School of Public Health: collaborator
• Universidad Catolica de Cordoba: collaborator
• University of Chile: collaborator
• Universidad de Sucre: collaborator
• Universidad del Magdalena: collaborator

Study Sites (1)

Universidad de Cartagena

Cartagena, Departamento de Bolívar, 130012, Colombia

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole human DNA from blood samples. Microbiome DNA sample from oral-pharyngeal mucose samples.

MeSH Terms

Conditions

Cardiovascular Diseases; Pulmonary Disease, Chronic Obstructive; Respiratory Insufficiency; Atherosclerosis; Noncommunicable Diseases

Interventions

Diet; Exercise

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• GUSTAVO J MORA-GARCIA, PhD

  Universidad de Cartagena

  PRINCIPAL INVESTIGATOR

• VANESSA GARCIA-LARSEN, PhD

  BLOOMBERG SCHOOL OF PUBLIC HEALTH JOHNS HOPKINS UNIVERSITY

  STUDY DIRECTOR

• MARIA S RUIZ-DIAZ, PhD

  NATIONAL CENTER FOR RESEARCH IN CHRONIC DISEASES

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: April 14, 2022
• First Posted: April 21, 2022
• Study Start: October 3, 2020
• Primary Completion: October 2, 2023
• Study Completion (Estimated): October 2, 2034
• Last Updated: April 21, 2022

Record last verified: 2022-04

Locations

CO (1)