Cardiometabolic Risk Factors Registry | NCT04040777

Studies
Cardiometabolic Risk Factors Registry

NCT04040777

Sponsor

Austral University, Argentina

Status

Recruiting

Last Update Posted

Jun 11, 2024Actual

Enrollment

25,000Estimated

Phase

Not provided

Conditions

Atherosclerosis
Metabolic Syndrome
Diabetes
Cardiovascular Risk Factor
Cardiovascular Diseases
Obesity

Interventions

Not provided

Countries

Argentina

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2015Actual

Primary Completion Date

Dec 2030Estimated

Completion Date

Dec 2030Estimated

First Submitted Date

Jul 30, 2019

First Submission Date that Met QC Criteria

Jul 30, 2019

First Posted Date

Aug 1, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 8, 2024

Last Update Posted Date

Jun 11, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Maria Julia Cremona, Coordinator of Clinical Research Department, Austral University, ArgentinaPrincipal Investigator

Lead Sponsor

Austral University, ArgentinaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

25,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Maximo A Schiavone, MD	Contact			maximoschiavone@gmail.com

Overall Officials

Name	Affiliation	Role
Maximo A Schiavone, MD	Austral University, Argentina	Principal Investigator
Sergio Gonzalez, MD	Austral University, Argentina	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Universitario Austral	Recruiting	Pilar	Buenos Aires	1631	Argentina

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D050197	Atherosclerosis
D024821	Metabolic Syndrome
D003920	Diabetes Mellitus
D002318	Cardiovascular Diseases
D009765	Obesity

Ancestor Terms

ID	Term
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases
D007333	Insulin Resistance

Browse Leaves

Not provided

Browse Branches

Not provided