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Enrolling by Invitation

NCT Number: NCT05339048

The Cartagena Cohort Study

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.

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Key information

Conditions

Cardiovascular Diseases Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Lung Function Decreased Noncommunicable Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Universidad de Cartagena

Cartagena, Departamento de Bolívar, 130012, Colombia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Genetic risk variants

Genetic

Exposure: Genetic predisposition to complex diseases.

Diet

Other

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

Physical activity

Behavioral

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

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).

Primary outcomes

  1. Atherosclerosis

    Time frame: baseline - 10 years (end of follow up)

    Carotid atheroma identified by eco-doppler imaging test

  2. Acute cardiovascular event

    Time frame: 2nd year (first follow up) - 10 years (end of follow up)

    Record of acute coronary heart disease, miocardipathy, and ischemic or hemorragic cerebrovascular event.

  3. Chronic airflow obstruction

    Time frame: baseline - 10 years (end of follow up)

    Obstruction patterns in post-bronchodilator spirometry.

  4. Metabolic syndrome

    Time frame: 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)

Secondary outcomes

  1. Chronic Obstructive Pulmonary Disease (COPD)

    Time frame: baseline - 10 years (end of follow up)

    Diagnosis of by lung function test (post-bronchodilator spirometry) and/or clinical criteria

  2. Hypertension

    Time frame: baseline - 10 years (end of follow up)

    Primary high blood pressure according to clinical criteria

  3. Type 2 Diabetes Mellitus

    Time frame: baseline - 10 years (end of follow up)

    Abnormal results in fasting serum glucose test and/or HbA1c test.

  4. Dyslipidemia

    Time frame: baseline - 10 years (end of follow up)

    High serum cholesterol, triglycerides or LDLc; and/or low HDLc

Sponsors and collaborators

Lead sponsor

Universidad de Cartagena

Other

Collaborators

  • 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

Registry information

Official study title

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

Acronym: CaReS

Important dates

Study start
2020
Primary completion
2023
Study completion
2034
First posted
Apr 21, 2022
Registry last updated
Apr 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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