Cardiovascular Registry of Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— LACROSS  

Official title:

Cardiovascular Registry of Atrial Fibrillation in Latin America: The LACROSS Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04456842
• Other study ID #: 001/2018
• Status: Recruiting
• Start date: August 4, 2020
• Est. completion date: September 2024

Study information

• Verified date: February 2023
• Source: Brazilian Clinical Research Institute
• Contact: Renato D. Lopes, MD, PhD
• Phone: 55 11 5904 7339
• Email: renato.lopes[@]duke.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: September 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Flutter

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Argentina	Hospital Interzonal General de Agudos "Dr. José Penna"	Bahía Blanca	Buenos Aires
Argentina	Hospital Italiano de La Plata	Buenos Aires	La Plata
Argentina	Centro Medico Luquez	Córdoba
Argentina	DIM Clínica Privada	Ramos Mejía	Buenos Aires
Argentina	Prevención Cardiovascular Salta	Salta
Argentina	Servicios Médicos El Castaño	San Juan
Argentina	Instituto Cardiovascular San Luis	San Luis
Argentina	Centro Modelo de Cardiologia	San Miguel De Tucumán	Tucumán
Argentina	Centro de Investigaciones Clinicas del Litoral SRL	Santa Fe
Argentina	Hospital Provincial Dr. José Maria Cullen	Santa Fe
Argentina	Centro de Investigaciones Medicas Temperley (CIMeT)	Temperley	Buenos Aires
Brazil	Hospital Alvorada Taguatinga Ltda	São Paulo
Colombia	Sociedad de Cirugia de Bogota - Hospital de San Jose	Bogotá	Cundinamarca
Colombia	Fundacion Valle del Lili	Cali	Valle Del Cauca
Mexico	Centro para el Desarrollo de la Medicina y de Asistecia Medica Especializada S.C.	Culiacán	Sinaloa
Mexico	Francisco Gerardo Padilla Padilla	Guadalajara	Jalisco
Mexico	Centro de Estudios Clínicos de Queretaro S.C. (CECLIQ)	Querétaro City	Querétaro

Sponsors (1)

Lead Sponsor	Collaborator
Brazilian Clinical Research Institute

Countries where clinical trial is conducted

Argentina,  Brazil,  Colombia,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	INR control rate		12 months
Primary	Oral anticoagulation discontinuation rate		12 months
Primary	Percentage of death		12 months
Primary	Percentage of stroke		12 months
Primary	Percentage of systemic embolism		12 months
Primary	Percentage of myocardial infarction		12 months
Primary	Percentage of major bleeding		12 months
Primary	Percentage of electrical cardioversion		12 months
Primary	Percentage of percutaneous ablation of AF		12 months
Primary	Percentage of atrioventricular junction ablation		12 months
Primary	Percentage of patients that need of pacemaker implantation		12 monts
Primary	Percentage of other cardiovascular hospitalization		12 months