Cardiovascular Registry of Atrial Fibrillation

Completed

• Conditions: Atrial Flutter; Atrial Fibrillation

• Registration Number: NCT04456842
• Lead Sponsor: Brazilian Clinical Research Institute

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2020-06-23
• Study First Submitted QC: 2020-07-01
• Study First Posted: 2020-07-07
• Study Start: 2020-08-04
• Status Verified: 2024-06
• Primary Completion: 2024-09-13
• Study Completion: 2024-09-30
• Last Update Submitted: 2024-10-03
• Last Update Posted: 2024-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2016

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of major bleeding	12 months
INR control rate	12 months
Oral anticoagulation discontinuation rate	12 months
Percentage of systemic embolism	12 months
Percentage of electrical cardioversion	12 months
Percentage of other cardiovascular hospitalization	12 months
Percentage of atrioventricular junction ablation	12 months
Percentage of patients that need of pacemaker implantation	12 monts
Percentage of death	12 months
Percentage of stroke	12 months
Percentage of myocardial infarction	12 months
Percentage of percutaneous ablation of AF	12 months

Trial Locations

Locations (17)

Centro para el Desarrollo de la Medicina y de Asistecia Medica Especializada S.C.; 🇲🇽 Culiacán, Sinaloa, Mexico

Hospital Italiano de La Plata; 🇦🇷 Buenos Aires, La Plata, Argentina

DIM Clínica Privada; 🇦🇷 Ramos Mejía, Buenos Aires, Argentina

Centro Medico Luquez; 🇦🇷 Córdoba, Argentina

Prevención Cardiovascular Salta; 🇦🇷 Salta, Argentina

Centro de Investigaciones Clinicas del Litoral SRL; 🇦🇷 Santa Fe, Argentina

Hospital Alvorada Taguatinga Ltda; 🇧🇷 São Paulo, Brazil

Sociedad de Cirugia de Bogota - Hospital de San Jose; 🇨🇴 Bogotá, Cundinamarca, Colombia

Fundacion Valle del Lili; 🇨🇴 Cali, Valle Del Cauca, Colombia

Centro de Estudios Clínicos de Queretaro S.C. (CECLIQ); 🇲🇽 Querétaro City, Querétaro, Mexico

Hospital Interzonal General de Agudos "Dr. José Penna"; 🇦🇷 Bahía Blanca, Buenos Aires, Argentina

Centro de Investigaciones Medicas Temperley (CIMeT); 🇦🇷 Temperley, Buenos Aires, Argentina

Instituto Cardiovascular San Luis; 🇦🇷 San Luis, Argentina

Servicios Médicos El Castaño; 🇦🇷 San Juan, Argentina

Hospital Provincial Dr. José Maria Cullen; 🇦🇷 Santa Fe, Argentina

Centro Modelo de Cardiologia; 🇦🇷 San Miguel De Tucumán, Tucumán, Argentina

Francisco Gerardo Padilla Padilla; 🇲🇽 Guadalajara, Jalisco, Mexico