Cardiovascular Registry of Atrial Fibrillation (LACROSS)

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

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

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Atrial Flutter
• Intervention / Treatment: Other: Patient Registry Data

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 Type: Observational
• Enrollment (Actual): 2016

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patient with Atrial Fibrilation or Atrial Flutter

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Brazilian Clinical Research Institute
• Investigators: Study Chair: Renato D. Lopes, MD, PhD, Instituto Brasileiro de Pesquisa Thomaz de Carvalho - BCRI

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2020
• Primary Completion (Actual): September 13, 2024
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: June 23, 2020
• First Submitted That Met QC Criteria: July 1, 2020
• First Posted (Actual): July 7, 2020

Study Record Updates

• Last Update Posted (Actual): October 4, 2024
• Last Update Submitted That Met QC Criteria: October 3, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Antithrombotic therapy; Atrial Flutter; Atrial Fibrilation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Atrial Flutter
• Other Study ID Numbers: 001/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No