The Cartagena Cohort Study

Cardiovascular Diseases Clinical Trial

— CaReS  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05339048
• Other study ID #: CCS
• Status: Enrolling by invitation
• Start date: October 3, 2020
• Est. completion date: October 2, 2034

Study information

• Verified date: April 2022
• Source: Universidad de Cartagena
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 619
• Est. completion date: October 2, 2034
• Est. primary completion date: October 2, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Cardiovascular Diseases
• COPD
• Lung Function Decreased

Intervention

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).

Locations

Country	Name	City	State
Colombia	Universidad de Cartagena	Cartagena de Indias	Bolivar

Sponsors (8)

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

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Atherosclerosis	Carotid atheroma identified by eco-doppler imaging test	baseline - 10 years (end of follow up)
Primary	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)
Primary	Chronic airflow obstruction	Obstruction patterns in post-bronchodilator spirometry.	baseline - 10 years (end of follow up)
Primary	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	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)
Secondary	Hypertension	Primary high blood pressure according to clinical criteria	baseline - 10 years (end of follow up)
Secondary	Type 2 Diabetes Mellitus	Abnormal results in fasting serum glucose test and/or HbA1c test.	baseline - 10 years (end of follow up)
Secondary	Dyslipidemia	High serum cholesterol, triglycerides or LDLc; and/or low HDLc	baseline - 10 years (end of follow up)