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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05339048
Other study ID # CCS
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
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
Health authority
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

Study Design


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)
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