Cardiovascular Registry of Atrial Fibrillation (LACROSS)

October 25, 2023 updated by: Brazilian Clinical Research Institute

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

Recruiting

Conditions

Intervention / Treatment

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 (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Córdoba, Argentina
        • Recruiting
        • Centro Medico Luquez
        • Contact:
          • Hugo Armando Luquez, MD
      • Salta, Argentina
        • Recruiting
        • Prevención Cardiovascular Salta
        • Contact:
          • Carlos Cuneo, MD
      • San Juan, Argentina
        • Recruiting
        • Servicios Médicos El Castaño
        • Contact:
          • Moira Alvarez, MD
      • San Luis, Argentina
        • Recruiting
        • Instituto Cardiovascular San Luis
        • Contact:
          • Juan Albisu, MD
      • Santa Fe, Argentina
        • Recruiting
        • Centro de Investigaciones Clinicas del Litoral SRL
        • Contact:
          • Miguel Hominal, MD
      • Santa Fe, Argentina
        • Recruiting
        • Hospital Provincial Dr. José Maria Cullen
        • Contact:
          • Cristian Edgardo Botta, MD
    • Buenos Aires
      • Bahía Blanca, Buenos Aires, Argentina
        • Recruiting
        • Hospital Interzonal General de Agudos "Dr. José Penna"
        • Contact:
          • Nadia Budassi, MD
      • Ramos Mejía, Buenos Aires, Argentina
        • Recruiting
        • Dim Clinica Privada
        • Contact:
          • Oscar Romano Montaña, MD
      • Temperley, Buenos Aires, Argentina
        • Recruiting
        • Centro de Investigaciones Medicas Temperley (CIMeT)
        • Contact:
          • Matias Nicolas Lugo, MD
    • La Plata
      • Buenos Aires, La Plata, Argentina
        • Recruiting
        • Hospital Italiano de La Plata
        • Contact:
          • Luis Cartasegna, MD
    • Tucumán
      • San Miguel De Tucumán, Tucumán, Argentina
        • Recruiting
        • Centro Modelo de Cardiologia
        • Contact:
          • Juan Antonio Muntaner, MD
  • Brazil
      • São Paulo, Brazil
        • Recruiting
        • Hospital Alvorada Taguatinga Ltda
        • Contact:
  • Colombia
    • Cundinamarca
      • Bogotá, Cundinamarca, Colombia
        • Recruiting
        • Sociedad de Cirugía de Bogotá - Hospital de San José
        • Contact:
          • Alejandro Olaya Sánchez, MD
    • Valle Del Cauca
      • Cali, Valle Del Cauca, Colombia
        • Recruiting
        • Fundacion Valle del Lili
        • Contact:
          • Luis Fernando Pava, MD
  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico
        • Recruiting
        • Francisco Gerardo Padilla Padilla
        • Contact:
          • Francisco Gerardo Padilla Padilla, MD
    • Querétaro
      • Querétaro City, Querétaro, Mexico
        • Recruiting
        • Centro de Estudios Clínicos de Queretaro S.C. (CECLIQ)
        • Contact:
          • Marco Antonio Alcocer Gamba, MD
    • Sinaloa
      • Culiacán, Sinaloa, Mexico
        • Recruiting
        • Centro para el Desarrollo de la Medicina y de Asistecia Medica Especializada S.C.
        • Contact:
          • Manuel Odin de Los Rios Ibarra, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brazilian Clinical Research Institute

Investigators

  • Study Chair: Renato D. Lopes, MD, PhD, Instituto Brasileiro de Pesquisa Thomaz de Carvalho - BCRI

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 4, 2020

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

September 1, 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 26, 2023

Last Update Submitted That Met QC Criteria

October 25, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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