Cardiovascular DiseasesCaReSNCT05339048
The Cartagena Cohort Study
An observational study of Cardiovascular Diseases and COPD, run by Universidad de Cartagena at 1 site in Colombia.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, COPD, Lung Function Decreased
- What is being tested?
- Genetic risk variants, Diet and Physical activity
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 619 participants
- Where
- 1 siteColombia
- Study dates
- 3 Oct 2020to 2 Oct 2034
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults, men and women, living on Colombian Caribbean Coast.
Who may be able to join
- Adults
- Native from Colombian Caribbean Coast
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Colombia1 site
Universidad de Cartagena
Cartagena, Departamento de Bolívar, 130012
About this study
Official title: Observational Study for the Analysis of Associations Between Cardiovascular and Respiratory Diseases in a Cohort of Latin American Adults
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.
Read more
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.
- Being tested
- Genetic risk variants, Diet, Physical activity, Socio-economic conditions
- Keywords
- Low and middle income countries, Non-communicable diseases, Latin America, Cardio-respiratory disease
- Medical subject headings
- Cardiovascular Diseases, Pulmonary Disease, Chronic Obstructive, Respiratory Insufficiency, Atherosclerosis, Noncommunicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetic risk variantsGenetic
Exposure: Genetic predisposition to complex diseases.
DietOther
Exposure: dietary intake of unhealthy foods known to be associated with higher prevalence of respiratory and cardiovascular diseases.
Physical activityBehavioural
Exposure: frequency of moderated or intense physical activity, and daily exposure to sedentary behavior.
Socio-economic conditionsOther
Exposure: socio-economic vulnerability indexes associated with higher prevalence of respiratory and cardiovascular diseases (including household conditions, accessibility to health care services, among others).
| Study group | Role | What they receive |
|---|---|---|
| General group | 18-80 years old adults from the Colombian Caribbean Coast. Receives: Genetic: Genetic risk variants; Other: Diet; Behavioral: Physical activity; Other: Socio-economic conditions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atherosclerosis
Carotid atheroma identified by eco-doppler imaging test
Measured: baseline - 10 years (end of follow up)
Acute cardiovascular event
Record of acute coronary heart disease, miocardipathy, and ischemic or hemorragic cerebrovascular event.
Measured: 2nd year (first follow up) - 10 years (end of follow up)
Chronic airflow obstruction
Obstruction patterns in post-bronchodilator spirometry.
Measured: baseline - 10 years (end of follow up)
Metabolic syndrome
Pathologic findings for blood pressure, triglycerides, HDLc, serum glucose, and/or enlarged waist circumference (three or more of this criteria found simultaneously)
Measured: baseline - 10 years (end of follow up)
Secondary outcomes (4)
Chronic Obstructive Pulmonary Disease (COPD)
Diagnosis of by lung function test (post-bronchodilator spirometry) and/or clinical criteria
Measured: baseline - 10 years (end of follow up)
Hypertension
Primary high blood pressure according to clinical criteria
Measured: baseline - 10 years (end of follow up)
Type 2 Diabetes Mellitus
Abnormal results in fasting serum glucose test and/or HbA1c test.
Measured: baseline - 10 years (end of follow up)
Dyslipidemia
High serum cholesterol, triglycerides or LDLc; and/or low HDLc
Measured: baseline - 10 years (end of follow up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start3 Oct 2020
- Primary completion2 Oct 2023 (estimated)
- Study completion2 Oct 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 619 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Universidad de Cartagena
- Sponsor type
- University, hospital or other
- Collaborators
- The Administrative Department of Science, Technology and Innovation, Colciencias, National Center for Research in Chronic Diseases, Colombia, Johns Hopkins Bloomberg School of Public Health, Universidad Catolica de Cordoba, University of Chile, Universidad de Sucre, Universidad del Magdalena
- Responsible party
- Principal investigator, Gustavo Mora Garcia, Universidad de Cartagena
- Investigators
- GUSTAVO J MORA-GARCIA, PhD, Principal investigator, Universidad de CartagenaVANESSA GARCIA-LARSEN, PhD, Study director, BLOOMBERG SCHOOL OF PUBLIC HEALTH JOHNS HOPKINS UNIVERSITYMARIA S RUIZ-DIAZ, PhD, Study chair, NATIONAL CENTER FOR RESEARCH IN CHRONIC DISEASES
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05339048
- Sponsor's protocol ID
- CCS
- Acronym
- CaReS
- Status last verified
- Apr 2022
- First submitted
- 14 Apr 2022
- Last updated
- 21 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Documents (i.e., study protocol, informed consent, and laboratory test) and study database are being save on a secure server at https://redcap.unicartagena.edu.co/redcap/ Sharing of study protocol, statistical analysis plan and analytic code is awaiting to be discussed by the research team.
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study for the Analysis of Associations Between Cardiovascular and Respiratory Diseases in a Cohort of Latin American Adults
- ClinicalTrials.gov ID
- NCT05339048
- Acronym / sponsor ID
- CaReS / CCS
- Keywords
- Low and middle income countries, Non-communicable diseases, Latin America, Cardio-respiratory disease
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 619 participants (estimated)
- Lead sponsor
- Universidad de CartagenaUniversity, hospital or other
- Collaborators
- The Administrative Department of Science, Technology and Innovation, Colciencias, National Center for Research in Chronic Diseases, Colombia, Johns Hopkins Bloomberg School of Public Health, Universidad Catolica de Cordoba, University of Chile, Universidad de Sucre, Universidad del Magdalena
- Study start
- 3 Oct 2020 (actual)
- Primary completion
- 2 Oct 2023 (estimated)
- Study completion
- 2 Oct 2034 (estimated)
- First posted
- 21 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| General group | – | Genetic: Genetic risk variants, Other: Diet, Behavioral: Physical activity, Other: Socio-economic conditions18-80 years old adults from the Colombian Caribbean Coast. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults, men and women, living on Colombian Caribbean Coast.
Key inclusion criteria (2 listed)
- Adults
- Native from Colombian Caribbean Coast
Key exclusion criteria (6 listed)
- Pregnant women
- Walking physical disability
- Cognitive disability
- Patients under treatment for any type of cancer
- Clinical record of primary chronic endocrine disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genetic risk variantsExposure: Genetic predisposition to complex diseases. | Genetic | General group |
| DietExposure: dietary intake of unhealthy foods known to be associated with higher prevalence of respiratory and cardiovascular diseases. | Other | General group |
| Physical activityExposure: frequency of moderated or intense physical activity, and daily exposure to sedentary behavior. | Behavioural | General group |
| Socio-economic conditionsExposure: socio-economic vulnerability indexes associated with higher prevalence of respiratory and cardiovascular diseases (including household conditions, accessibility to health care services, among others). | Other | General group |
Primary outcome
Atherosclerosis
Time frame: baseline - 10 years (end of follow up)
Carotid atheroma identified by eco-doppler imaging test
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.
Chronic airflow obstruction
Time frame: baseline - 10 years (end of follow up)
Obstruction patterns in post-bronchodilator spirometry.
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)
4 secondary outcomes
Chronic Obstructive Pulmonary Disease (COPD)
Time frame: baseline - 10 years (end of follow up)
Hypertension
Time frame: baseline - 10 years (end of follow up)
Type 2 Diabetes Mellitus
Time frame: baseline - 10 years (end of follow up)
Dyslipidemia
Time frame: baseline - 10 years (end of follow up)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
- Individual participant dataSharing planned: Undecided. Documents (i.e., study protocol, informed consent, and laboratory test) and study database are being save on a secure server at https://redcap.unicartagena.edu.co/redcap/ Sharing of study protocol, statistical analysis plan and analytic code is awaiting to be discussed by the research team.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
GUSTAVO J MORA-GARCIA, PhD principal investigator
Universidad de Cartagena
VANESSA GARCIA-LARSEN, PhD study director
BLOOMBERG SCHOOL OF PUBLIC HEALTH JOHNS HOPKINS UNIVERSITY
MARIA S RUIZ-DIAZ, PhD study chair
NATIONAL CENTER FOR RESEARCH IN CHRONIC DISEASES
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and COPD, run by Universidad de Cartagena at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 21 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atherosclerosis (time frame: baseline - 10 years (end of follow up)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2022.