AtherosclerosisCARFARENCT04040777
Cardiometabolic Risk Factors Registry
An observational study of Atherosclerosis and Metabolic Syndrome, run by Austral University, Argentina at 1 site in Argentina.
Trial summary
CARFARE (CARDIOMETABOLIC RISK FACTORS REGISTRY) is a registry done in the context of a cardiovascular primary prevention program of the Cardiometabolic Unit Officia of the Cardiology Department of the Austral University Hospital. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis, Metabolic Syndrome, Diabetes
- How many people
- 25,000 participants
- Where
- 1 siteArgentina
- Study dates
- Jun 2015to Dec 2030
- How long will I take part?
- 5 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary prevention population. Most of the population are low and moderate cardiovascular risk.
Who may be able to join
- Age >18 years old.
Who cannot join
- Previous cardiovascular and/or cerebrovascular event
- stable chronic angina
- advanced chronic kidney disease (Stage IV or V)
- cancer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Maximo A Schiavone, MD contact
Argentina1 site, 1 recruiting
- Recruiting
Hospital Universitario Austral
Pilar, Buenos Aires, 1631
Maximo A. Schiavone, MD, maximoschiavone@gmail.com
Fabian Ferroni, MD, FFERRONI@cas.austral.edu.ar
About this study
CARFARE (CARDIOMETABOLIC RISK FACTORS REGISTRY) is a registry done in the context of a cardiovascular primary prevention program of the Cardiometabolic Unit Officia of the Cardiology Department of the Austral University Hospital. The structured and sequential evaluation include measurement of anthropometric parameters (body mass index, BMI), laboratory with metabolic profile, baseline electrocardiogram, blood pressure (BP) measurement, arterial stiffness, subclinical atherosclerosis screening in the carotid and ileo-femoral territories using echo-doppler, echocardiogram, and ergometry test.
- Conditions
- Atherosclerosis, Metabolic Syndrome, Diabetes, Cardiovascular Risk Factor, Cardiovascular Diseases, Obesity
- Keywords
- Subclinical Atherosclerosis, Metabolic Syndrome, Primary Prevention
- Medical subject headings
- Atherosclerosis, Metabolic Syndrome, Diabetes Mellitus, Cardiovascular Diseases, Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Major Adverse Cardiovascular Events (MACE)
Inicidence of myocardial infarction, stroke, unstable angina or acute heart failure
Measured: 5 years
Mortality rate
Death due to MACE or other causes
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study startJun 2015
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 25,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Austral University, Argentina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Julia Cremona, Austral University, Argentina
- Investigators
- Maximo A Schiavone, MD, Principal investigator, Austral University, ArgentinaSergio Gonzalez, MD, Study director, Austral University, Argentina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04040777
- Sponsor's protocol ID
- 19-044
- Acronym
- CARFARE
- Status last verified
- Jun 2024
- First submitted
- 30 Jul 2019
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiometabolic Risk Factors Registry
- ClinicalTrials.gov ID
- NCT04040777
- Acronym / sponsor ID
- CARFARE / 19-044
- Conditions
- Atherosclerosis, Metabolic Syndrome, Diabetes, Cardiovascular Risk Factor, Cardiovascular Diseases, Obesity
- Keywords
- Subclinical Atherosclerosis, Metabolic Syndrome, Primary Prevention
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25,000 participants (estimated)
- Lead sponsor
- Austral University, ArgentinaUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 1 Aug 2019 (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.
CARFARE (CARDIOMETABOLIC RISK FACTORS REGISTRY) is a registry done in the context of a cardiovascular primary prevention program of the Cardiometabolic Unit Officia of the Cardiology Department of the Austral University Hospital. The structured and sequential evaluation include measurement of anthropometric parameters (body mass index, BMI), laboratory with metabolic profile, baseline electrocardiogram, blood pressure (BP) measurement, arterial stiffness, subclinical atherosclerosis screening in the carotid and ileo-femoral territories using echo-doppler, echocardiogram, and ergometry test.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary prevention population. Most of the population are low and moderate cardiovascular risk.
Key inclusion criteria (1 listed)
- Age >18 years old.
Key exclusion criteria (4 listed)
- Previous cardiovascular and/or cerebrovascular event
- stable chronic angina
- advanced chronic kidney disease (Stage IV or V)
- cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Major Adverse Cardiovascular Events (MACE)
Time frame: 5 years
Inicidence of myocardial infarction, stroke, unstable angina or acute heart failure
Mortality rate
Time frame: 5 years
Death due to MACE or other causes
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 11 Jun 2024.
- Individual participant dataSharing planned: No
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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.
Maximo A Schiavone, MD contact
Maximo A Schiavone, MD principal investigator
Austral University, Argentina
Sergio Gonzalez, MD study director
Austral University, Argentina
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 Atherosclerosis and Metabolic Syndrome, run by Austral University, Argentina at 1 site in Argentina.
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 1 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 11 Jun 2024. 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 Argentina. 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?
Contact Maximo A Schiavone, MD (maximoschiavone@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Major Adverse Cardiovascular Events (MACE) (time frame: 5 years). The study lists 2 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 11 Jun 2024.