Clinical trial NCT04456842: Cardiovascular Registry of Atrial Fibrillation
Official title: Cardiovascular Registry of Atrial Fibrillation in Latin America: The LACROSS Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Atrial Flutter
Keywords: Atrial Fibrilation
Antithrombotic therapy
Atrial Flutter
Lead sponsor: Brazilian Clinical Research Institute
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 2016
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient with Atrial Fibrilation or Atrial Flutter

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.

Eligibility criteria: 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.

Primary outcomes:
measure: INR control rate
timeFrame: 12 months
measure: Oral anticoagulation discontinuation rate
timeFrame: 12 months
measure: Percentage of death
timeFrame: 12 months
measure: Percentage of stroke
timeFrame: 12 months
measure: Percentage of systemic embolism
timeFrame: 12 months
measure: Percentage of myocardial infarction
timeFrame: 12 months
measure: Percentage of major bleeding
timeFrame: 12 months
measure: Percentage of electrical cardioversion
timeFrame: 12 months
measure: Percentage of percutaneous ablation of AF
timeFrame: 12 months
measure: Percentage of atrioventricular junction ablation
timeFrame: 12 months
measure: Percentage of patients that need of pacemaker implantation
timeFrame: 12 monts
measure: Percentage of other cardiovascular hospitalization
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bahía Blanca
country: Argentina
facility: Hospital Interzonal General de Agudos "Dr. José Penna"
state: Buenos Aires
city: Ramos Mejía
country: Argentina
facility: DIM Clínica Privada
state: Buenos Aires
city: Temperley
country: Argentina
facility: Centro de Investigaciones Medicas Temperley (CIMeT)
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de La Plata
state: La Plata
city: San Miguel De Tucumán
country: Argentina
facility: Centro Modelo de Cardiologia
state: Tucumán
city: Córdoba
country: Argentina
facility: Centro Medico Luquez
city: Salta
country: Argentina
facility: Prevención Cardiovascular Salta
city: San Juan
country: Argentina
facility: Servicios Médicos El Castaño
city: San Luis
country: Argentina
facility: Instituto Cardiovascular San Luis
city: Santa Fe
country: Argentina
facility: Centro de Investigaciones Clinicas del Litoral SRL
city: Santa Fe
country: Argentina
facility: Hospital Provincial Dr. José Maria Cullen
city: São Paulo
country: Brazil
facility: Hospital Alvorada Taguatinga Ltda
city: Bogotá
country: Colombia
facility: Sociedad de Cirugia de Bogota - Hospital de San Jose
state: Cundinamarca
city: Cali
country: Colombia
facility: Fundacion Valle del Lili
state: Valle Del Cauca
city: Guadalajara
country: Mexico
facility: Francisco Gerardo Padilla Padilla
state: Jalisco
city: Querétaro City
country: Mexico
facility: Centro de Estudios Clínicos de Queretaro S.C. (CECLIQ)
state: Querétaro
city: Culiacán
country: Mexico
facility: Centro para el Desarrollo de la Medicina y de Asistecia Medica Especializada S.C.
state: Sinaloa
Study officials:
affiliation: Instituto Brasileiro de Pesquisa Thomaz de Carvalho - BCRI
name: Renato D. Lopes, MD, PhD
role: STUDY_CHAIR
References: