Cardiovascular Diseases Clinical Trial
— CaReSOfficial title:
Observational Study for the Analysis of Associations Between Cardiovascular and Respiratory Diseases in a Cohort of Latin American Adults
Verified date | April 2022 |
Source | Universidad de Cartagena |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Colombia | Universidad de Cartagena | Cartagena de Indias | Bolivar |
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 |
Colombia,
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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