NCT04040777

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25,000

participants targeted

Target at P75+ for all trials

Timeline
56mo left

Started Jun 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress71%
Jun 2015Dec 2030

Study Start

First participant enrolled

June 1, 2015

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

July 30, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 1, 2019

Completed
11.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

June 11, 2024

Status Verified

June 1, 2024

Enrollment Period

15.5 years

First QC Date

July 30, 2019

Last Update Submit

June 8, 2024

Conditions

Keywords

Subclinical AtherosclerosisMetabolic SyndromePrimary Prevention

Outcome Measures

Primary Outcomes (2)

  • Incidence of Major Adverse Cardiovascular Events (MACE)

    Inicidence of myocardial infarction, stroke, unstable angina or acute heart failure

    5 years

  • Mortality rate

    Death due to MACE or other causes

    5 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary prevention population. Most of the population are low and moderate cardiovascular risk.

You may qualify if:

  • Age \>18 years old.

You may not qualify if:

  • Previous cardiovascular and/or cerebrovascular event
  • stable chronic angina
  • advanced chronic kidney disease (Stage IV or V)
  • cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Austral

Pilar, Buenos Aires, 1631, Argentina

RECRUITING

MeSH Terms

Conditions

AtherosclerosisMetabolic SyndromeDiabetes MellitusCardiovascular DiseasesObesity

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Maximo A Schiavone, MD

    Austral University, Argentina

    PRINCIPAL INVESTIGATOR
  • Sergio Gonzalez, MD

    Austral University, Argentina

    STUDY DIRECTOR

Central Study Contacts

Maximo A Schiavone, MD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Coordinator of Clinical Research Department

Study Record Dates

First Submitted

July 30, 2019

First Posted

August 1, 2019

Study Start

June 1, 2015

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Last Updated

June 11, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations