Cardiovascular Registry of Atrial Fibrillation

NCT ID: NCT04456842

Last Updated: 2024-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2016 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-04

Study Completion Date

2024-09-30

Brief Summary

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Follow a representative sample of Latin American patients diagnosed with atrial fibrillation to set data on demographic characteristics, documenting antithrombotic therapy, describe the INR control level of VKA users, discontinuation rates and clinical outcomes, such as stroke, hemorrhage and death

Detailed Description

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Patients will be followed 6 months and 1 year after the baseline visit and will be collected data of antithrombotic therapy, laboratory data, discontinuation rates of antithrombotic therapy and clinical outcomes.

Conditions

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Atrial Fibrillation Atrial Flutter

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Patient Registry Data

To set data on demographic characteristics,documenting antithrombotic therapy, describe the INR control level of VKA users, discontinuation rates and clinical outcomes, such as stroke, hemorrhage and death.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age \> 18 years-old that signed informed consent;
* Atrial Fibrillation or Atrial Flutter at the time of inclusion documented in source document;
* If the patient is not in atrial fibrillation or Atrial Flutter rhythm, s/he should have 2 electrographic records, at least 15 days apart between them, with one of them being performed within the last 6 months before enrollment (AF may be documented by 12-lead ECG, Holter monitor-24h);

Exclusion Criteria

* Patients who did not agree to participate.
* Patients without possibility of monitoring for one year.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brazilian Clinical Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Renato D. Lopes, MD, PhD

Role: STUDY_CHAIR

Instituto Brasileiro de Pesquisa Thomaz de Carvalho - BCRI

Locations

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Hospital Interzonal General de Agudos "Dr. José Penna"

Bahía Blanca, Buenos Aires, Argentina

Site Status

DIM Clínica Privada

Ramos Mejía, Buenos Aires, Argentina

Site Status

Centro de Investigaciones Medicas Temperley (CIMeT)

Temperley, Buenos Aires, Argentina

Site Status

Hospital Italiano de La Plata

Buenos Aires, La Plata, Argentina

Site Status

Centro Modelo de Cardiologia

San Miguel de Tucumán, Tucumán Province, Argentina

Site Status

Centro Medico Luquez

Córdoba, , Argentina

Site Status

Prevención Cardiovascular Salta

Salta, , Argentina

Site Status

Servicios Médicos El Castaño

San Juan, , Argentina

Site Status

Instituto Cardiovascular San Luis

San Luis, , Argentina

Site Status

Centro de Investigaciones Clinicas del Litoral SRL

Santa Fe, , Argentina

Site Status

Hospital Provincial Dr. José Maria Cullen

Santa Fe, , Argentina

Site Status

Hospital Alvorada Taguatinga Ltda

São Paulo, , Brazil

Site Status

Sociedad de Cirugia de Bogota - Hospital de San Jose

Bogotá, Cundinamarca, Colombia

Site Status

Fundacion Valle del Lili

Cali, Valle del Cauca Department, Colombia

Site Status

Francisco Gerardo Padilla Padilla

Guadalajara, Jalisco, Mexico

Site Status

Centro de Estudios Clínicos de Queretaro S.C. (CECLIQ)

Querétaro City, Querétaro, Mexico

Site Status

Centro para el Desarrollo de la Medicina y de Asistecia Medica Especializada S.C.

Culiacán, Sinaloa, Mexico

Site Status

Countries

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Argentina Brazil Colombia Mexico

Other Identifiers

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001/2018

Identifier Type: -

Identifier Source: org_study_id

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