The Cartagena Cohort Study

• Conditions: Cardiovascular Diseases; COPD; Lung Function Decreased; Atherosclerosis
• Interventions: Genetic: Genetic risk variants; Other: Diet; Behavioral: Physical activity; Other: Socio-economic conditions

• Registration Number: NCT05339048
• Lead Sponsor: Universidad de Cartagena

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-03
• Status Verified: 2022-04
• Study First Submitted: 2022-04-14
• Study First Submitted QC: 2022-04-14
• Last Update Submitted: 2022-04-14
• Study First Posted: 2022-04-21
• Last Update Posted: 2022-04-21
• Primary Completion: 2023-10-02
• Study Completion: 2034-10-02

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 619

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
General group	Genetic risk variants	18-80 years old adults from the Colombian Caribbean Coast.
General group	Diet	18-80 years old adults from the Colombian Caribbean Coast.
General group	Physical activity	18-80 years old adults from the Colombian Caribbean Coast.
General group	Socio-economic conditions	18-80 years old adults from the Colombian Caribbean Coast.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Universidad de Cartagena; 🇨🇴 Cartagena de Indias, Bolivar, Colombia