- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04040777
Cardiometabolic Risk Factors Registry (CARFARE)
June 8, 2024 updated by: Maria Julia Cremona, Austral University, Argentina
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 Overview
Status
Recruiting
Study Type
Observational
Enrollment (Estimated)
25000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Maximo A Schiavone, MD
- Email: maximoschiavone@gmail.com
Study Locations
-
-
Buenos Aires
-
Pilar, Buenos Aires, Argentina, 1631
- Recruiting
- Hospital Universitario Austral
-
Contact:
- Maximo A. Schiavone, MD
- Email: maximoschiavone@gmail.com
-
Contact:
- Fabian Ferroni, MD
- Email: FFERRONI@cas.austral.edu.ar
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Primary prevention population.
Most of the population are low and moderate cardiovascular risk.
Description
Inclusion Criteria:
- Age >18 years old.
Exclusion Criteria:
- Previous cardiovascular and/or cerebrovascular event
- stable chronic angina
- advanced chronic kidney disease (Stage IV or V)
- cancer
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of Major Adverse Cardiovascular Events (MACE)
Time Frame: 5 years
|
Inicidence of myocardial infarction, stroke, unstable angina or acute heart failure
|
5 years
|
|
Mortality rate
Time Frame: 5 years
|
Death due to MACE or other causes
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Maximo A Schiavone, MD, Austral University, Argentina
- Study Director: Sergio Gonzalez, MD, Austral University, Argentina
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2015
Primary Completion (Estimated)
December 1, 2030
Study Completion (Estimated)
December 1, 2030
Study Registration Dates
First Submitted
July 30, 2019
First Submitted That Met QC Criteria
July 30, 2019
First Posted (Actual)
August 1, 2019
Study Record Updates
Last Update Posted (Actual)
June 11, 2024
Last Update Submitted That Met QC Criteria
June 8, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-044
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.